A COMMUNITY BASED STUDY TO EVALUATE THE EFFICACY OF CHATURJATADI SAMBHARAKA ON THE NUTRITIONAL STATUS OF CHILDREN WITH BALSHOSHA W.S.R. TO PROTEIN ENERGY MALNUTRITION

A COMMUNITY BASED STUDY TO EVALUATE THE EFFICACY OF CHATURJATADI SAMBHARAKA ON THE NUTRITIONAL STATUS OF CHILDREN WITH BALSHOSHA W.S.R. TO PROTEIN ENERGY MALNUTRITION

Vedprakash Meena * and Nisha Kumari Ojha

Department of Kaumarbhritya - Balroga, National Institute of Ayuveda, Jaipur, Rajasthan, India.

ABSTRACT: Introduction: The aim was this trial is to assess to evaluate the effect of “Chaturjatadi Sambharaka” in the management of malnutrition in Children. Material and methods: This research work was done in two phases. Phase one included demographic study and in phase two was clinical study. A Randomized open label-controlled trial was conducted on100 undernourished children of 1-10 years of age group. Total cases were divided into two groups (50 in each). In Group A, only Nutritional Rehabilitation (As per ICMR guidelines) was administered whereas in Group B, Nutritional Rehabilitation (As per ICMR guidelines) along with the trial drug Chaturjatadi Sambharaka was administered. The trial drug was administered in Avleha form in a dose 180-200 mg/kg/day in divided dose or 8 weeks and post follow up was done after month. Scoring of chief clinical features was done before and after treatment. Result: The clinical efficacy of the drug was analysed statistically on all parameters mentioned in the Assessment criteria. Both groups, showed statistically significant (P<0.001) improvement on anthropometric parameters- Weight, Height, BMI, MUAC, SFT, and Chest circumference. However, on Intergroup comparison, group B showed statistically significant advantage over group A (p<0.001). The trial (Group B) showed significant improvement on laboratory investigations in Hemoglobin level, Total Serum Protein and A: G ratio (p<0.001). Conclusion: The trial group (Group B) which included Chaturjatadi Sambharaka along with nutritional rehabilitation was effective in the management of PEM/Balshosha due to its therapeutic and nutritional properties: Deepana, Pachana, Balya, Brimhana, and Rasayana.

Keywords: Balshosha, Deepana, Pachana, Brimhana, Protein energy malnutrition, Chaturajatadi Sambharaka

INTRODUCTION: The term malnutrition includes both under nutrition as well as over nutrition and it is defined by low weight –for-age(underweight), length-for-age (stunting) or weight-for-length (wasting) ¹. Childhood under nutrition is widely recognized as major health problem in developing countries due to its disastrous consequences on development of child both physically and psychologically.

It is estimated that most of the children of preschool-age group are suffering from severe wasting. Under nutrition can be defined in children aged 6–59 months, as moderate wasting and/or mid-upper-arm circumference (MUAC) less than 125 mm². The most important element of our population is children, due not only to their sheer numbers, but also because the basis for adult life is built throughout these formative years.

Furthermore, these children will play a significant role in determining the quality of our future human resource. As a result, the well-being of these youngsters is critical to the country's development. The nutritional quality of children throughout their most susceptible and growing years builds the groundwork for excellent health in later years. Studies on growth and physical development of infants and children are crucial determinants of health. At this age, malnutrition causes growth retardation, poor health, decreased efficiency, and a lower level of social production.

Many factors are responsible in the causation of malnutrition but poverty, unemployment, illiteracy, poor personal hygiene, low availability of health care facilities and inadequate food distribution system are the major factors of malnutrition. Malnourished children are more prone to systemic infection because Infections worsen malnutrition by reducing appetite, causing catabolism, and raising nutrient need. The level of weight loss and growth rate varies with the severity of PEM, i.e., failure to maintain weight or growth rate in the early stages, but as the disease progresses, damage to the immune system occurs, which can lead to infection, shock, and death. Poor nutrition affects motor sensory, cognitive, social and emotional development. It is most deadly disease and may be called as “Silent killer” as it is associated with a wide variety of morbidities as their underlying cause in children. Malnutrition leads to ill health as well as poor immunity.

For the first time UNICEF, WHO and the World Bank reported joint estimates of child malnutrition for 2011. Estimates of prevalence and numbers for child stunting, underweight, and wasting are presented by United Nations, Millennium Development Goal, UNICEF, WHO regional and World Bank income group classifications. According to this estimate, in 2011, an estimated 165 million children under five years of age worldwide were stunted (low height for age below-2SD). High prevalence levels of stunting among children less than five years of age in Africa (36% in 2011) and Asia (27% in 2011). In 2011, an estimated 101 million children under five years of age worldwide were underweight (low weight for age below-2SD). Globally, an estimated 52 million children under five years of age were wasted (Weight for height below -2SD) in 2011. Seventy percent of the world’s wasted children in Asia, most in South-Central Asia.

As per WHO assessment, in 2020, 47 million children under the age of five will be wasted, 14.3 million will be severely wasted, and 144 million will be stunted. In 2020, undernutrition will be responsible for almost 45 percent of fatalities among children mal the age of five. Low and middle-income countries are the most affected. The global burden of malnutrition has substantial and long-term developmental, economic, social, and medical consequences.

MATERIAL AND METHODS:

Study Type: A Randomized open label-controlled trial was conducted. The study was conducted under a strict protocol to prevent bias and to reduce the sources of error in the study.

Aim: To evaluate the effect of “Chaturjatadi Sambharaka” in the management of malnutrition.

Selection of Cases:

Source: Subjects attending the O.P.D and I.P.D. of Kaumarbhritya Department of National Institute of Ayurveda, Jaipur was screened for the present study.

Age Group: Children of 01 to 10 years of age were selected for the study.

Number of Cases: 100 cases (50 patients in each group).

Grouping of Cases: Total cases were divided into two groups.

Group A: 50 cases (Nutritional Rehabilitation)

Group B: 50 cases (Nutritional Rehabilitation + Trial Drug).

Criteria for Selection of Patients: All children within the age group 01 year to 10 years were subjected to detailed clinical examination and anthropometric measurement to screen out subjects suffering from varying degree of malnutrition according to the criteria as specified by Indian Academy of Paediatrics. A randomized study was conducted in children suffering from mild to moderate malnutrition.

Inclusion Criteria:

1. Children aged 01 year to 10 years of either sex suffering from mild-to-moderate degree of malnutrition with good appetite and no major complication (criteria as specified by IAP).
2. Mother and care taker trainable to provide home based diet.
3. Parents or caretaker willing to participate in the clinical trial.
4. Not planning to leave the study area for the coming 04 months.

Exclusion Criteria:

1. Children with age <01 year or age >10 year.
2. Children suffering from severe malnutrition (IAP criteria) with no appetite and complications, like Hypothermia, respiratory distress (presence of tachypnoea, intercostal recession), Extensive skin lesion/infection, lethargic, unconscious, Presence of convulsions, Severe dehydration based on history & clinical signs, Any condition that requires an infusion or NG tube feeding and Blood haemoglobin less than 06 gm/dl.
3. Tuberculosis
4. Cerebral palsy
5. Congenital heart diseases
6. Known metabolic disorders
7. Known mal-absorption syndromes
8. Chromosomal malformations
9. Renal or hepatic disorders
10. Caretakers not willing to participate in the study

Discontinuation Criteria:

1. Any other acute illness.
2. Parents not willing to continue.
3. Any adverse effect of drug during trial.

Grouping of Patients: Cases registered for the study and satisfying inclusion criteria were divided into two groups. The subjects were enrolled by appropriate randomization technique.

Group A: Nutritional Rehabilitation: Dietary counselling and nutritional rehabilitation was done so that the child took recommended daily allowances as suggested by age specific Indian council of medical research (ICMR) guidelines.

Group B: Nutritional Rehabilitation Along with Trial Drug (ChaturjatadiSambharaka): Patients in this group received “ChaturjatadiSambharaka” along with dietary counselling and nutritional rehabilitation.

TABLE 1: TRIAL DRUG, CHATURJATA DISAMBHARAKA (GADANIGRAHA, BALROGADHIKARA, 11/77-79

Method of Drug Preparation: The compound was in form of Avaleha in order to enhance its palatability and easy administration in children. The trial drug was prepared in the pharmacy of National institute of Ayurveda, Jaipur.

Dose: 180-200mg/kg/day. The proposed trial drug, was prescribed in doses according to body weight of children for 08 weeks and follow up was done fortnightly. Doses were calculated according to Clarks Formula.

Duration: 08 weeks

Assessment Criteria: The result of the clinical study was assessed based on the observations of clinical features, anthropometric parameters and laboratory findings. Following parameters was adopted for assessing the patients before and after treatment:

• Clinical (Clinical features and Anthropometric parameters).
• Laboratory Parameters.

Clinical Assessment: It was done on the basis of clinical features of Balshosha anthropometric parameters.

Clinical Features: Assessment of clinical features (Arochaka, Jwara, Pratishyaya, Kasa, Mukha Snigdhata, Mukha Shwetata, Netra Snigdhata, Netra Shwetata, Shwasa, Shothaa and Kesha Shushkata) depending on the severity was done on four-point scale

Nil - G0, Mild - G1, Moderate - G2, Severe - G3

Anthropometry Parameters:

1. Weight for age criteria.
2. Body mass index (B.M.I.).
3. Mid arm circumference (M.A.C) in cm.
4. Skin fold thickness (S.F.T.) in cm or mm
5. Height in cm.
6. Chest circumference in cm.

Laboratory Parameters:

1. Hb%, DLC, TLC, ESR.
2. Total protein level.
3. Serum albumin.
4. A: G ratio.

Adverse Effect Evaluation Criteria: To rule out the possible adverse effect of studied drug clinical criteria was adopted and was documented in AEEF (Adverse Effect Evaluation Format) during the course of the study.

Follow-Up: All patients were followed on an interval of 2 weeks i.e. on day 14, day 28, 42 and day 56 after recruitment. A window period of ±3 days was given to allow for holidays and weekends.

Proforma: The protocol required information was collected on each patient using printed proforma (Informed consent/ Case record form). Updated case record forms was kept safe for data analysis.

Ethical Clearance: Ethical clearance of the present trial obtained from Institutional Ethics Committee, after deliberation on 8^th & 9^th May Reference No. IEC/ACA/2019/1-19, National Institute of Ayurveda, Jaipur.

CTRI Registration: Prior to the start the clinical trial was applied for registration in CTRI with reference number REF/2020/07/035175 and CTRI with Registration No. CTRI/2020/09/53338.

Statistical Analysis: Group comparisons for continuously distributed data were made using independent sample‘t’ test when comparing two groups. If data were found to be non-normally distributed, appropriate non-parametric tests in the form of Wilcoxon Test were used. Chi-squared test was used for group comparisons for categorical data. In case the expected frequency in the contingency tables was found to be <5 for >25% of the cells, Fisher’s exact test was used. Repeated measures were analyzed using Paired t-test/Wilcoxon Signed Rank Test.

RESULTS:

TABLE 2: SUMMARY OF BASIC DETAILS

TABLE 3: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN WEIGHT (KG) OVER TIME  (N =50)

TABLE 4: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN HEIGHT (CM) OVER TIME  (N = 50)

TABLE 5: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN BMI (KG/M2) OVER TIME (N = 50)

TABLE 6: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN SFT (MM) OVER TIME (N = 50)

TABLE 7: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN MUAC (CM) OVER TIME (N = 50)

TABLE 8: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN CHEST CIRCUMFERENCE (CM) OVER TIME (N = 50)

Changes in Clinical Features: Figure Number is to be written in place of Chart Number:

TABLE 9: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN HEMOGLOBIN (G/DL) OVER TIME (N = 50)

TABLE 10: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN ESR OVER TIME (N = 50)

TABLE 11: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN TOTAL PROTEINS (G/DL) OVER TIME (N = 50)

TABLE 12: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN SERUM ALBUMIN (G/DL) OVER TIME (N = 50)

TABLE 13: COMPARISON OF THE TWO GROUPS IN TERMS OF CHANGE IN A: G RATIO OVER TIME (N = 50)

DISCUSSION: In present study, patients were treated in two individual Groups. In Group A Nutritional Rehabilitation and in Group B Nutritional Rehabilitation along withTrial drug (Chaturjatadi Sambharaka) were administered. Both the groups received standard diet according to their grade of malnutrition and body weight. The results were observed and evaluated for anthropometric variables, clinical symptoms and laboratory parameters at the end of entire course.

The clinical efficacy of the drug was analyzed statistically on all parameters mentioned in the Assessment criteria. A scoring structure was employed to evaluate the effectiveness of therapy. Scoring of chief clinical features was done before and after treatment. Thus, Group comparisons for continuously distributed data were made using independent sample‘t’ test when comparing two groups. If data were found to be non-normally distributed, appropriate non-parametric tests in the form of Wilcoxon Test were used. Chi-squared test was used for group comparisons for categorical data. In case the expected frequency in the contingency tables was found to be <5 for >25% of the cells, Fisher’s exact test was used. Repeated measures were analyzed using Paired t-test/Wilcoxon Signed Rank Test. Statistical significance was kept at p < 0.05. More specific quantification of the percentage improvement in each feature the formula BT-AT/BT x 100 was applied. All the parameters adopted i.e. anthropometric variables, clinical features and laboratory values were statistically analyzed and after that results of every parameter are being discussed hereunder.

Effect on Anthropometric Variables:

Weight: The mean Weight (Kg) was 15.86 ± 5.48. The Weight (Kg) ranged from 7 – 26. In Group: A, the mean Weight (Kg) increased from a minimum of 16.17 at the Before Treatment time point to a maximum of 16.59 at the After Treatment time point. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean Weight (Kg) increased from a minimum of 15.50 at the Before Treatment time point to a maximum of 18.15 at the After Treatment time point. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of Weight (Kg) over time between the two groups (p = <0.001).

Height: The mean Height (cm) was 108.45± 17.21. The Height (cm) ranged from 68 – 141. In Group: A, the mean Height (cm) increased from a minimum of 106.52 at the Before Treatment timepoint to a maximum of 107.52 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean Height (cm) increased from a minimum of 110.61 at the Before Treatment timepoint to a maximum of 113.08 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of Height (cm) over time between the two groups (p = <0.001).

BMI: The mean BMI (Kg/m2) was 13.07± 1.40. The BMI (Kg/m2) ranged from 10.4 - 16.3. In Group: A, the mean BMI (Kg/m2) increased from a minimum of 13.69 at the Before Treatment timepoint to a maximum of 13.83 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 381.0, p = 0.021). In Group: B, the mean BMI (Kg/m2) increased from a minimum of 12.38 at the Before Treatment timepoint to a maximum of 14.08 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of BMI (Kg/m2) over time between the two groups (p = <0.001).

SFT: The mean SFT (mm) was 4.84 ± 1.13. The SFT (mm) ranged from 4 - 7.5. In Group: A, the mean SFT (mm) increased from a minimum of 4.77 at the Before Treatment timepoint to a maximum of 4.86 at the After Treatment timepoint.

This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean SFT (mm) increased from a minimum of 4.90 at the Before Treatment timepoint to a maximum of 5.00 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was no significant difference in the trend of SFT (mm) over time between the two groups (p = 0.471).

MUAC: The mean MUAC (cm) was 12.74 ± 0.91. The MUAC (cm) ranged from 11 - 14.8. In Group: A, the mean MUAC (cm) increased from a minimum of 13.34 at the Before Treatment timepoint to a maximum of 13.80 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean MUAC (cm) increased from a minimum of 12.14 at the Before Treatment timepoint to a maximum of 13.74 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of MUAC (cm) over time between the two groups (p = <0.001).

Chest Circumference: The mean Chest Circumference (cm) was 57.34 ± 5.18. The Chest Circumference (cm) ranged from 48 – 66.In Group: A, the mean Chest Circumference (cm) increased from a minimum of 57.23 at the Before Treatment timepoint to a maximum of 57.86 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean Chest Circumference (cm) increased from a minimum of 57.44 at the Before Treatment timepoint to a maximum of 58.65 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of Chest Circumference (cm) over time between the two groups (p = <0.001).

After 56 days of intervention, it was observed that, significant improvement was observed in all anthropometric parameters. This could be attributed to Snigdha, Pichchhila, Guru, Brimhana and Rasayana properties of the drug which helps to nourish the Rasa, Mamsa, Medodhatu.

Thus, on overall evaluation in group B patients who were on trial drug had a better outcome in comparison to group A who were only on nutritional rehabilitation. This may be because drug compound acts on the pathogenesis of Balshosha, by breaking it and by balancing of Agni. Drug promotes appetite; enhance bioavailability of nutrients and acts as anabolic agent, thus increasing quantity of diet to be taken and best utilisation of it to form body tissues. Thus, assimilation of nutrients is better due balanced Agni and there is rapid recovery with formation of Prashasta dhatus(best tissue quality) in group B.

On individual analysis of groups; both the groups show significant results in anthropometric parameters but on intergroup analysis group B showed significant advantage over Group A. Results point out that standard diet has good effect on anthropometric parameters but with administration of drug, a very prompt and superior outcome can be achieved.

Effect on Clinical Features of Balshosha:

Arochaka: In Group: A, the mean Arochaka decreased from a maximum of 1.28 at the Before Treatment timepoint to a minimum of 0.94 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 153.0, p = <0.001). In Group: B, the mean Arochaka decreased from a maximum of 1.36 at the Before Treatment timepoint to a minimum of 0.14 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 1176.0, p = <0.001). There was a significant difference in the trend of Arochaka over time between the two groups (p = <0.001).

Jwara: In Group: A, the mean Jwara decreased from a maximum of 1.04 at the Before Treatment timepoint to a minimum of 0.58 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 231.0, p = <0.001). In Group: B, the mean Jwara decreased from a maximum of 1.04 at the Before Treatment timepoint to a minimum of 0.14 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 861.0, p = <0.001). There was a significant difference in the trend of Jwara over time between the two groups (p = <0.001).

Pratishyaya: In Group: A, the mean Pratishyaya decreased from a maximum of 1.06 at the Before Treatment timepoint to a minimum of 0.64 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 231.0, p = <0.001). In Group: B, the mean Pratishyaya decreased from a maximum of 1.02 at the Before Treatment timepoint to a minimum of 0.14 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 861.0, p = <0.001). There was a significant difference in the trend of Pratishyaya over time between the two groups (p = <0.001).

Kasa: In Group: A, the mean Kasa decreased from a maximum of 1.02 at the Before Treatment timepoint to a minimum of 0.58 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 231.0, p = <0.001). In Group: B, the mean Kasa decreased from a maximum of 0.88 at the Before Treatment timepoint to a minimum of 0.18 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 595.0, p = <0.001). There was a significant difference in the trend of Kasa over time between the two groups (p = 0.012).

Shwasa: In Group: A, the mean Shwasa decreased from a maximum of 0.90 at the Before Treatment timepoint to a minimum of 0.44 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 276.0, p = <0.001). In Group: B, the mean Shwasa decreased from a maximum of 0.76 at the Before Treatment timepoint to a minimum of 0.06 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 561.0, p = <0.001). There was a significant difference in the trend of Shwasa over time between the two groups (p = 0.021).

Mukha Snigdhata: In Group: A, the mean Mukha Snigdhata decreased from a maximum of 1.06 at the Before Treatment timepoint to a minimum of 0.64 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 231.0, p = <0.001). In Group: B, the mean MukhaSnigdhata decreased from a maximum of 0.86 at the Before Treatment timepoint to a minimum of 0.26 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 465.0, p = <0.001). There was no significant difference in the trend of MukhaSnigdhata over time between the two groups (p = 0.067).

Netra Snigdhata: In Group: A, the mean NetraSnigdhata decreased from a maximum of 0.94 at the Before Treatment timepoint to a minimum of 0.52 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 231.0, p = <0.001). In Group: B, the mean NetraSnigdhata decreased from a maximum of 0.72 at the Before Treatment timepoint to a minimum of 0.22 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 300.0, p = <0.001). There was no significant difference in the trend of NetraSnigdhata over time between the two groups (p = 0.439).

MukhaShwetata: In Group: A, the mean MukhaShwetata decreased from a maximum of 1.12 at the Before Treatment timepoint to a minimum of 0.74 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 190.0, p = <0.001). In Group: B, the mean MukhaShwetata decreased from a maximum of 0.82 at the Before Treatment timepoint to a minimum of 0.18 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 496.0, p = <0.001). There was a significant difference in the trend of MukhaShwetata over time between the two groups (p = 0.010).

Netra Shwetata: In Group: A, the mean NetraShwetata decreased from a maximum of 1.16 at the Before Treatment timepoint to a minimum of 0.72 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 253.0, p = <0.001). In Group: B, the mean NetraShwetata decreased from a maximum of 0.92 at the Before Treatment timepoint to a minimum of 0.20 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 595.0, p = <0.001). There was a significant difference in the trend of NetraShwetata over time between the two groups (p = 0.006).

Shotha: In Group: A, the mean Shotha decreased from a maximum of 0.66 at the Before Treatment timepoint to a minimum of 0.38 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 105.0, p = <0.001). In Group: B, the mean Shotha decreased from a maximum of 0.42 at the Before Treatment timepoint to a minimum of 0.10 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 136.0, p = <0.001). There was no significant difference in the trend of Shotha over time between the two groups (p = 0.662).

Kesh Shushkata: In Group: A, the mean KeshShushkata decreased from a maximum of 0.64 at the Before Treatment timepoint to a minimum of 0.34 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 120.0, p = <0.001). In Group: B, the mean KeshShushkata decreased from a maximum of 0.48 at the Before Treatment timepoint to a minimum of 0.12 at the After Treatment timepoint, This change was statistically significant (Wilcoxon Test: V = 171.0, p = <0.001). There was no significant difference in the trend of KeshShushkata over time between the two groups (p = 0.523).

Effect on Laboratory Parameters:

Hemoglobin: In Group: A, the mean Hemoglobin (g/dL) increased from a minimum of 10.79 at the Before Treatment timepoint to a maximum of 11.58 at the After Treatment timepoint. This change was statistically significant (Paired t-test: t = -11.2, p = <0.001). In Group: B, the mean Hemoglobin (g/dL) increased from a minimum of 11.01 at the Before Treatment timepoint to a maximum of 13.08 at the After Treatment timepoint. This change was statistically significant (Paired t-test: t = -21.7, p = <0.001). There was a significant difference in the trend of Hemoglobin (g/dL) over time between the two groups (p = <0.001).

ESR: In Group: A, the mean ESR decreased from a maximum of 15.08 at the Before Treatment timepoint to a minimum of 14.10 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 903.0, p = <0.001). In Group: B, the mean ESR decreased from a maximum of 14.12 at the Before Treatment timepoint to a minimum of 10.17 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 1275.0, p = <0.001). There was a significant difference in the trend of ESR over time between the two groups (p = <0.001).

Total Serum Protein: In Group: A, the mean Total Serum Protein (g/dL) increased from a minimum of 5.48 at the Before Treatment timepoint to a maximum of 6.07 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean Total Proteins (g/dL) increased from a minimum of 5.61 at the Before Treatment timepoint to a maximum of 6.87 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of Total Serum Protein (g/dL) over time between the two groups (p = <0.001).

Serum Albumin: In Group: A, the mean Serum Albumin (g/dL) increased from a minimum of 3.94 at the Before Treatment timepoint to a maximum of 4.41 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). In Group: B, the mean Serum Albumin (g/dL) increased from a minimum of 4.37 at the Before Treatment timepoint to a maximum of 4.58 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 0.0, p = <0.001). There was a significant difference in the trend of Serum Albumin (g/dL) over time between the two groups (p = <0.001).

A: G Ratio: In Group: A, the mean A:G Ratio increased from a minimum of 3.22 at the Before Treatment timepoint to a maximum of 3.51 at the After Treatment timepoint. This change was not statistically significant (Wilcoxon Test: V = 508.5, p = 0.303). In Group: B, the mean A:G Ratio decreased from a maximum of 3.95 at the Before Treatment timepoint to a minimum of 2.07 at the After Treatment timepoint. This change was statistically significant (Wilcoxon Test: V = 1273.0, p = <0.001). There was a significant difference in the trend of A:G Ratio over time between the two groups (p = <0.001).On overall analysis of laboratory parameters trial drug treated group B has significant improvement in Hemoglobin level, Total Serum Protein and A:G ratio. Group A showed not significant effects in improvement in A: G ratio.

Probable Action of the Drug: Chaturjatadi Sambharaka ³ is a well-balanced preparation including the drugs having Deepana, Pachana, Vatanulomana, Krimighna, Jwara, Aruchi, Kasa, Shwasa, Kandu, Chhardi-Hrilashanashana, Vishahara, Rasayana, Brumhana, Vrushya, Balya ⁴ properties which are very much essential in a Shosha predominant disease. Chaturjatadi Sambharaka including the drugs Dalchini, Ela, Tejpatra, Nagkeshara, Talishpatra, Kushtha, Shunthi, Maricha, Pippali, Chavya, Pippalimula, Tavaksheera, Shweta Jeera, Ashwagandha, Khanda (Sharkara) and Ghrita.

The drug possesses mainly katu, tikta and madhurarasa, madhuravipaka, sheeta as well as ushnavirya. The properties of contents are balancing each other having laghu as well as guru, snigdha and ruksha, tikshna properties. They are mainly Kapha-Vatashamaka and have therapeutic properties like Agnideepana, Amapachana, Balya, Brimhana, Rasayana,   Dhatuvardhaka, Ojovardhaka, and Srotoshodhaka etc.

Because of these properties, there is nourishment to the dhatus as well as it improves shosha (wasting of tissues) and increase body weight. Moreover, Madhura rasa is considered as satmya for children in consideration to their age. The other dominant rasa is Katu rasa which is formed by Vayu and Agni mahabhuta thereby it controls Agni, also increase the absorption of food, increases interest in food, open blocked channels (srotoshodhaka), Kledanashaka, and is Kaphashamaka. Thus by these properties it breaks the pathogenesis of Agnimandya janya srotorodha which is root cause of Balshosha. Whole metabolism in our body is accelerated by Katu rasa that helps in absorption of micro as well macronutrients as per requirement in the body and thus decline nutrient deficiencies. The Tikata rasa is Deepana-Pachana, Krimighna, Arochakaghna, Srotoshodhaka and digest the Ama formed in the disease process. Laghuguna is called Pathya, Kaphaghna, Lekhana and is easily digestible due to which the drug get easily absorbed. By these properties it relieves the obstruction of Rasavahasrotasa by Kapha and is suitable to digest by disarranged Agni in Balshosha patients. The Laghu-Rukshaguna also increase the diminished Agni and helps to digest the Pathyaahara. The Snigdhaguna alleviates Rukshata and Kharata of dhatus by its Snehana and Mridukarana properties.

It also promotes the strength (Bala) in patients. The other properties of the drug include Ruksha which by its Stambhana action provide stability to Asthira dhatus. The Guru gunapresent in drug by its Tarpana and Brimhana actions increases the mass of body tissues. Madhura Vipakais considered Sarvadhatuposhaka, Balya and Brihmana. The SheetaVirya is favorable in childhood by its Mridu, Balya, Brimhana and Rasayana action on dhatus. UsnaVirya alleviates Kapha dosha & Ama.

The pharmacological actions which are useful in malnutrition are digestive, bioavailability enhancer, hepto-protective, immunomodulator, antioxidant, antimicrobial, antiviral, antidiarrheal, antibacterial and growth promoting etc. Twak (Cinnamomum zeylanicum) has antimicrobial property ⁵. Ela (Elettaria cardamomum) has immunomodulatory ⁶ and antioxidant effect ⁷. Tejapatra (Cinnamomum tamala) has antibacterial effect ⁸. Tavaksheera (Bambusaarundinacea) has Pancreas protective and hepatoprotective effect⁹. Kushtha (Saussurealappa) has anticancerous effect ¹⁰. Nagkeshara (Mesuaferrea) has antioxidant effect ¹¹. Shunthi (Zingiber officinale) has anti-inflammatory, anti-tumour and antioxidant activities ¹². Maricha (Piper nigrum) has antimicrobial, antioxidant, anti inflammatory and neuroprotective effect ¹³. Pippali (Piperlongum) has immunomodulatory activity ¹⁴ and bioavailability enhancer ¹⁵ Chavya (Piper retrofractum) has gastroprotective and cholesterol-lowering properties ¹⁶. ShvetaJeeraka (Cuminum cyminum) has anti inflammatory, antioxidant and immunological activity ¹⁷. Ashwagandha (Withania somnifera) has muscle mass promotive activity, improvement in the physical performance and strength ¹⁸. Sharkara (Saccharum officinarum) has antioxidants effect¹⁹. Cow ghee has Agnideepana, Anubhishyandi, Ayushya, Balya, Chakshushya, Deepana, Hridya, Kantiprada, Medhya, Ojovardhaka, Rasayana ²⁰, digestive, antioxidants, energetic, anti toxic, medhyarasayana and nourishing Property ²¹.

CONCLUSION: In the present randomized clinical trial, both groups, showed statistically significant (P<0.001) improvement on anthropometric parameters- Weight, Height, BMI, MUAC, SFT, and Chest circumference. However, on Intergroup comparison, group B (trial group) showed statistically significant advantage over group A (p<0.001). The trial drug (Group B) was also effective in improving clinical features of Balshosha/PEM as reflected in statistical result: significant (p< 0.001) in Arochaka, Jwara, Pratishyaya, Kasa, Mukha Snigdhata, Mukha Shwetata, Netra Snigdhata, Netra Shwetata, Shwasa, Shotha and Kesh Shushkata.

The trial drug (Group B) showed significant improvement on laboratory investigations in Hemoglobin level, Total Serum Protein and A:G ratio (p<0.001). The overall change over time was compared in the two groups A and B, there was a significant difference on Anthropometric Parameters- Weight, Height, BMI, MUAC and Chest Circumference (p <0.001) and not significant difference on SFT. The overall change over time was compared in the two groups A and B, there was a significant difference in clinical features of Balshosha/PEM -Arochaka, Jwara, Pratishyaya, Kasa, MukhaShwetata, Netra Shwetata, and Shwasa(p <0.001) and not significant difference in MukhaSnigdhata,Netra Snigdhata, Shotha and Kesh Shushkata.

The overall change over time was compared in the two groups A and B, there was a significant difference on laboratory investigations in Hemoglobin, TLC, Neutrophils, Lymphocytes, Monocyte, ESR , Total Proteins, Serum Albumin, A:G Ratio (p <0.001) and not significant difference in Basophil and Eosinophils. The trial drug (Group B) was effective in the management of PEM/Balshosha due to its therapeutic and nutritional properties: Deepana, Pachana, Balya, Brimhana,and Rasayana. No any adverse effects of the drug therapy were observed during the present study. The present study was done with a small sample of patients. The results obtained are just a preview of information for future researchers to study involving large sample size. It is expected that the further study on this project could be beneficial for the children suffering from Balashoshaw.s.r. to PEM.

ACKNOWLEDGEMENT: The authors are thankful to the institute for providing necessary facilities.

CONFLICTS OF INTEREST: The authors declare that there is no conflict of interest.

REFERENCES:

1. https://www.who.int/news-room/questions-and-answers/item/malnutrition Retrieved on 12-06-2021
2. https://www.who.int/data/nutrition/nlis/info/infant-and-young-child-feeding Retrieved on 12-06-2021.
3. Gadanigraha, of Sodhal with hindi commentary by Sri Indradev Tripathi, Chowkhamba Sanskrit Series Office, Varanasi; Balrogadhikara 11/77-79
4. Bhavprakash Nighantu of Sri Bhavmisra, Commentary by Prof. K.C. Chunekar; Edited by Dr.G. S. Pandey, Chaukhambha Bharati Academy; Varanasi Reprint Guduchyadi Varga 2013; 379.
5. Gupta C, Garg AP, Uniyal RC and Kumari A: Comparative analysis of the antimicrobial activity of cinnamon oil and cinnamon extract on some food-borne microbes. Afr J Microbiol Res 2008; 2: 247–251.
6. Majdalawieh AF and Carr RI: In-vitro investigation of the potential immunomodulatory and anti-cancer activities of black pepper (Piper nigrum) and cardamom (Elettaria cardamomum). J Med Food 2010; 13(2): 371-81.
7. Verma SK, Jain V and Katewa SS: Blood pressure lowering, fibrinolysis enhancing and antioxidant activities of cardamom (Elettaria cardamomum). Indian J Biochem Biophys 2009; 46(6): 503-6.
8. Rath S and Padhy RN: Monitoring in-vitro antibacterial efficacy of 26 Indian spices against multidrug resistant tract infecting bacteria. Integ Med Res 2014; 3(3): 133-41.
9. Ahmad D, Sharma M, Mukerjee A, Ramteke PW and Kumar V: Improved Glycemic control, pancreas protective and hepatoprotective effect by traditional poly-herbal formulation (ours tabasheer) in streptozocin induced diabetic rats. BMC Complement Altern Med 2013; 13-10. Doi 10.1186/1472-6882-13-10
10. Tian X Song, Cho HS, Park YM, Song B, YJ, Jang S & Kang SC: Anticancereffect of saussurealappa extract via dual control of apoptosis and autophagy in prostate cancer cells, Medicine 2017; 96(30): 7606.
11. Asif M, Shafaei A, Abdul Majid AS, Ezzat MO, Dahham SS, Ahmed MBK, Oon CE and Abdul Majid AMS: Mesuaferrea stem bark extract induces apoptosis and inhibits metastasis in human colorectal carcinoma hct 116 cells through modulation of multiple cell signaling pathways. Chin JNat Med 2017; 15(7): 505-514. Doi: 10.1016/s1875-5634(17)30076-6
12. Nagendra Chari KL, Manasa D, Srinivas P and Sowbhagya HB: Enzyme-assisted extraction of bioactive compounds from ginger (Zingiber officinale Roscoe). Food Chem 2013139: 509-514.
13. Takooree H, Aumeeruddy MZ, Rengasamy KRR, Venugopala KN, Jeewon R, Zengin G and Mahomoodally MF: A systematic review on black pepper (Piper nigrum L.): from folk uses to pharmacological applications. Crit Rev Food Sci Nutr 2019; 1-34.
14. Devan P, Bani S, Suri KA: Immunomodulation exhibited by piperinic acid of Piperlongum L; through suppression of proinflammatory cytokines. Int Immunopharmacol 2007; 7(7): 889-899.
15. Khajuria A, Thusu N and Zutshi U: Piperine modulates permeability characteristics of intestine by inducing alterations in membrane dynamics: influence on brush border membrane fluidity, ultrastructure and enzyme kinetics. Phytomedicine 2002; 9(3): 224-31.
16. Kim KJ: Piperidine alkaloids from Piper retrofractum protect against high-fat diet induced obesity by regulating lipid metabolism and activating AMP-activated protein kinase 2011; 411(1): 219-25. doi: 10.1016/j.bbrc.2011.06.153.
17. Ali Esmail Al-Snafi: The Pharmacological activities of Cuminumcyminum- A review. IOSR Journal of Pharmacy 2016; 6(6): 46-65
18. Raut AA, Rege NN, Tadvi FM, Solanki PV, Kene KR, Shirolkar SG, Pandey SN and Vaidya AB: Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. J Ayurveda Integr Med 2012; 3(3): 111-4.
19. Guan Y, Tang Q, Fu X, Yu S, Wu S and Chen M: Preparation of antioxidants from sugarcane molasses. Food Chem 2014; 152: 552-557.
20. API, Part-1 Vol-IV
21. Ankita Mahakalkar, Pranita Kashyap, Ram Bawankar and Bhushan Hatwar: The versatility of Cow Ghee – An Ayurveda Perspective. American Journal of Drug Delivery and Therapeutics 2014; 1(1): 028-034.
    

    ---

    How to cite this article:

    Meena V: A community based study to evaluate the efficacy of Chaturjatadi Sambharaka on the nutritional status of children with Balshosha W.S.R. to protein energy malnutrition. Int J Pharm Sci & Res 2023; 14(7): 3596-10. doi: 10.13040/IJPSR.0975-8232.14(7).3596-10.

    ---

    All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.