EVIDENCE BASED STUDY OF EFFECT OF SWARNA YOGA (GOLD FORMULATIONS) IN CHILDREN: A SYSTEMATIC REVIEW
HTML Full TextEVIDENCE BASED STUDY OF EFFECT OF SWARNA YOGA (GOLD FORMULATIONS) IN CHILDREN: A SYSTEMATIC REVIEW
Rashmi Pareek * and Nisha Ojha
P.G. Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur, Rajasthan, India.
ABSTRACT: Background: In the field of pediatrics, a number of herbo-metallic preparations are available which tend to enhance immunity in children. Various Ayurveda texts have mentioned these preparations, especially gold formulations like Swarna Prashan, Suvarnabindu, Suvarna Vacha, Kumarabharana Rasa etc. in children, and many clinical studies have also been published to establish their safety and efficacy. Material and Method: Subject-related published research articles from various journals were searched online through PubMed, Google Scholar and data of the articles were analyzed by following PICOS format to confirm their safety and efficacy in the paediatric population. Results: Total 7 clinical studies showing safety and efficacy of Ayurvedic herbo-metallic preparations in paediatric disorders such as Chronic tonsillitis, Upper Respiratory Tract Infection (URTI) and healthy children were treated with significant effect in their diseased condition and reducing the frequency of recurrent infections. No any adverse or toxic effect of any of these formulations was noticed. Conclusion: Gold preparations are found quite safe to use in pediatric disorders with proper dose and vehicle as well as in healthy children.
Keywords: Swarna prashan, Immunity, Children, Ayurveda, Gold
INTRODUCTION: In Ayurveda gold is having great importance, and its formulations are used from ancient time throughout the world for many purposes. In our classics, certain gold formulations are available which are supposed to enhance the immune power of children. It is believed that gold is used in Ayurvedic herbo-mineral preparations for the treatment of chronic and degenerative disease without any side effect. The use of bhasma from Gold, silver etc. metals and most herbo-mineral formulations of Ayurveda suffered because of some studies spoiled Ayurvedic herbo-mineral formulations as toxic and contaminated with lead, mercury, arsenic and other toxic compounds.
In the present era, immunomodulation is a strong need, especially in children who are more vulnerable for infections because of the underdeveloped immune system. There are many research studies available that show evidence of the safety and efficacy of gold preparations, but there are so many variations in methodology, formulations, etc. Hence, this type of systematic review may help us to answer the questions where the result is uncertain. Further, it will also confirm the relevance of current practice and whether there is a need to change our approach 1.
The present review edifies some of the gold preparations that were practised in Ayurveda like Swarna Prashan, Suvarnabindu, Suvarna Vacha, Kumarabharana Rasa, and Swarnamritaprashana. A present study has been conducted to evaluate the immunomodulatory effect of gold formulations mentioned in Ayurveda. Large numbers of formulations are mentioned in Ayurvedic classics. Here, an attempt was made to search the articles and compile them in a systematic format.
MATERIALS AND METHODS: Subject-related research articles published in various journals were searched and the data of the articles were analyzed to evaluate the safety and efficacy of gold formulations in children. This systematic review of studies on the efficacy of Swarna was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance 2. The search strategy included the Population, Intervention, Control, Outcome and Study design (PICOS) pattern 3 Data was extracted from research papers by using data extraction form 4.
Types of Participants: Patients or healthy volunteers of age <16 years were included in the review. The inclusion criteria for selections of patients varied study to study according to diseases.
RESULTS: This systematic review included seven studies on the efficacy of gold formulations, out of which results were obtained in PICOS format are mentioned below in Table 1.
TABLE 1: STUDIES CONTAINING GOLD PREPARATION
S. no. | Basic Information | Participants | Intervention | Comparison | Outcome | Study design |
1 | Rao N. Prasanna et al., 5 (2012) | n=30 3-8 year with URTI (Upper Respiratory Tract Infections) | Swarnmrita Prashana 1 ml daily empty stomach | Not included | Statistically significant relief
in signs and symptoms of URTI |
Not mentioned |
2 | Shailaja et al., 6 (2013)
|
n=16
Chronic tonsillitis Age: Between 5 and 10 years |
Kumarabharana Rasa 500 mg once
in the morning before meal with honey; Duration: 30 days |
Not mentioned | Statistical significant reversal
of fever, lymphadenopathy, and other signs and symptoms |
Pilot clinical study |
3 | Ramteke et al., 7 (2014) (RCT) | n=120
Physical growth parameters Age: Children up to 12 years |
Swarnaprashana 1 mg/kg body weight on every 27th day (Pushya nakshatra) for total 14 days (n=30male and 30 female)
Duration: 1 year and 15 days |
Control (n=30): Madhujala
Standard Group Control (n=30): Standard required measures
|
Significant (P<0.05) result
in weight gain of male and female children in relation with control group |
Randomised Control Trial |
4 | Arun raj et al., 8 (2016)
Nonrandomized controlled trial |
n=40
Chronic tonsillitis Age: Between 5 and 10 years |
Kumarabharana rasa 500 mg once
in the morning before meal with honey Duration: 30 days |
Godhuma Vati (placebo)
|
Statistically significant relief
in signs and symptoms as that of placebo control |
Open-labeled double-arm setting with a pre- and post-test design. |
5 | Dr.JaybhayVikas et al., 9 (2016) | n= 27
0-5 years |
Suvarna Prashan | Not included | Statistically significant increase in height, weight and head circumference | Open study design |
6 | PallaviDindore et al., 10 (2017) | N=40
3-4 year Healthy children |
Suvarnabhasma 4mg/dose suspended in ghrita and 4 drops of madhu
Duration 6 month |
Group B-No treatment | Statistically significant decrease in frequency, severity and duration of illness
Also found significant reduction in mood and temperament, behaviour complaints |
Open label, parallel, prospective and observational |
7 | Jyotsna Ahir et al., 11 (2018) | N=100
0-16 year with URTI |
Group A-Suvarna Prashana
5 drops upto 5 years and 5 drop+1 drop for each additional 1 year |
Group B-No treatment | Statistically significant relief
in signs and symptoms |
Not mentioned |
TABLE 2: FORMULATIONS OF SWARNA AVAILABLE IN CLASSICAL TEXT
S. no. | Reference | Aushadhi | Sahapana | Matra | Kala |
1 | Charaka (Ch. Sharir 8/46) | Madhu+Ghrita | - | - | At birth (Single dose) |
2 | Sushruta (Su. Sh.10/15) 12 | Swarna | Madhu+Ghrita | 1 Gunja
(Dalhana) |
As above |
3 | Ashtanga Samgraha
(Ashtang Samgraha Uttartantra 1/8) 13 |
Endri, Brahmi, Vacha & Shankhpushpi with Swarnaspoona | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | At birth (Single dose) |
Swarna, Brahmi, Bala, Shatavari | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | At birth (Single dose) | ||
Swarna | Madhu+Ghrita | 1 Gunja
(Dalhana) |
At birth (Single dose) | ||
Swarna & Vacha | Madhu+Ghrita | AlpaMatra | Till 1 year | ||
4 | Ashtang Hriday
(Ashtang Hriday Uttartantra 1/9) 14 |
Swarna, Brahmi, Vacha, Tapya & Haritaki | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | At birth (Single dose) |
Swarna and Amalaki | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | At birth (Single dose) | ||
5 | Sushruta (Su. Sh.10/73) & Ashtang Hriday (Ashtang Hriday Uttartantra 1/47-48) 15 | Swarna, Balavacha, Kushtha, Kaidarya, Vacha | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | Till 1 year |
Swarna & Arkapushpi | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | Till 1 year | ||
Swarna, Matsyakshaka & Shankha | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | Till 1 year | ||
Swarna, Kaidarya, Vacha | Madhu+Ghrita | 1 Harenu/ 1 Kalaya | Till 1 year | ||
6 | Sharangdhara (Sharangdhara PurvaKhanda 6/27) 16 | Swarnachurna | Madhu+Ghrita | 1 Gunja | As Above |
8 | BhaishajyaRatnavali (BhaishajyaRatnavali, 71/8) 17 | Swarna, Kushtha, Haritaki, Vacha, Brahmi | Madhu+Ghrita | 1 Ratti | - |
9 | Rasaratnasamucchaya 18
(22/136) |
Swarna, Kana (Pippali) | Madhu+Ghrita | 1/4thRatti | At birth (Single dose) |
11 | Kashyapa Samhita (Kashyapa Sutra Lehadhyay) 19 | Swarna | Madhu+Ghrita | Not given | Daily from birth to 1 month or 6 months of age |
DISCUSSION: In children, some herbo‑metallic formulations have also been used in routine practice as mentioned in Table 2. Since ancient times these formulations are extensively recommended by Ayurveda physicians. Previous researches also have proved antioxidant 20, anti-inflammatory, antibacterial and immunomodulatory activities of gold 21, 22.
Recent research shows that gold particles having anti-oxidant properties and T –lymphocyte activation and thus involve in the regulation of antigen-specific immune response 23. For the past several decade's Gold nanoparticles have come into the light, which is synthesized by using various methods, which include chemical and electrochemical radiation, photochemical method, and biological techniques 24. AuNPs (Gold nanoparticles) have potential stability over the antibacterial activities against gram-negative bacteria like E. coli, Pseudomonas aeruginosa, and gram-positive bacteria like Bacillus subtilis, respectively 25. Vacha (Acorus calamus) is also included in some of these formulations, which may be considered to help in relieving chronic stress-induced immunodeficiency 26. Some other study also suggests its immunomodulatory and anti-inflammatory properties 27. According to Charaka immature stage lasts up to 16 yr of age. During this period, Dhatus are undeveloped, various immature organs of the body. Moreover, Bala, Varna are not fully developed, and body is soft, which cannot tolerate any adversity 28. Therefore the use of herbometallic formulations in children may raise doubt of safety and toxicity. But in a recent study, the group of wistar male albino rats was administered Swarnabhasma in a dose of 5.625 mg/kg body weight along with 0.4 ml of ghee and honey by oral route for 90 days, and no significant behavioral change or mortality was noticed 29. Gold particles are the most promising ones which do not affect living cells and do not produce adverse effects 30.
In the studies mentioned above, which were included in this systematic review, most gold formulations have included ghee and honey as a vehicle that helps decrease the toxic level of gold ash. To overcome this toxic, synthesis of nanoparticles using biological conjugates such as proteins, peptides, oligonucleotide, polysaccharides, fatty acids, and amino acids might be done, reducing the toxic nature of the prepared nanoparticles 31. Honey is known to enhance the action of these medicines and has a potential immunomodulatory effect 32. One of the study conducted on ghee reports the antioxidant properties of the high CLA enriched ghee 33. Hence, honey and ghee are found to be beneficial in enhancing potency and reducing the toxic effect of gold formulations.
Strength of the Study: The articles were searched through the most popular databases and written in a proper scientific manner with possible scientific discussion and justification were included in this study. Data were obtained by using the standardised technique PICO format.
Limitations of the Study: Some articles may be located in other databases. Many articles of Ayurveda published earlier are still not available online, and some of the research work has not been published yet. Hence, studies from them could not be included in the study. Furthermore, only a few studies were reported with proper methodology and study design.
CONCLUSION: This review regarding the clinical trials conducted on the gold formulations suggests that these preparations seem to be safe and efficacious with their multidimensional approach as an immunomodulator for children. Formulations prepared by following proper methodology, dose, and vehicle are least likely to show any evidence of toxicity in children. However, well-planned studies with proper methodology are warranted to improve the evidence to establish Swarnaprashana to be used as an Ayurveda immunization technique.
ACKNOWLEDGEMENT: The authors are thankful to Vice-Chancellor Prof. Sanjeev Sharma, National Institute of Ayurveda (Deemed to be University), Jaipur, for providing necessary facilities.
CONFLICTS OF INTEREST: Nil
REFERENCES:
- Goyal M: Need of systematic review of clinical trials in Ayurveda. Ayu 2017; 38(3-4): 95-96.
- Moher D, Liberati A, Tetzlaff J and Altman DG: The PRISMA Group Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 2009; 6(7): e1000097.
- Higgins JPT and Green S: Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration. 2013
- Robertson C, Archibald D and Avenell A: Systematic reviews of and integrated report on the quantitative, qualitative and economic evidence base for the management of obesity in men. Southampton (UK): NIHR Journals Library; 2014 May. (Health Technology Assessment, No. 18.35.) Appendix 15, Data extraction form: qualitative review. Available from: https://www.ncbi.nlm.nih.gov/books/NBK262125/
- Prasanna NR, Shailja U, Mallika KJ, Desai, Sheetal and Parikshit D: Traditional use of swarnamritprasana as a preventive measure: Evidence based observational Study in children. Int J Res in Ayu Pharm 2012; 3(5): 634-38.
- Shailaja U, Prasanna NR, Raj GRA and Mallannavar V: Effect of Kumarabharana rasa in chronic tonsillitis of children: A pilot clinical study. Int J Res Ayurveda Pharm 2013; 4: 153‑
- Ramteke RD, Gawai VU, Sharma MV, Tawalare KA and Tawalare KK: Study the effect of SwarnaPrashan on Physical Growth Parameters of Weight and Height in Children; nternational Journal of Ayurvedic Medicine 2014; 5(3): 269-77.
- Raj GRA, Shailaja U, Debnath P, Banerjee S and Rao PN: Exploratory studies on the therapeutic effects of Kumarabharana Rasa in the management of chronic tonsillitis among children at a tertiary care hospital of Karnataka. J Tradit Complement Med 2015; 6(1): 29-33.
- Bharat JV: Role of SuvarnaPrashan in children upto five years of age. International Ayurvedic medical Journal {online} 2016 {cited 2016 July} Available from: http://www.iamj.in/posts/images/upload/3305_3310.pd
- Pallavi, Dindore, Aziz, Arbar, Kadam, Avinash and Vikas: Clinical effect of SuvarnaBinduPrashan. Journal of Ayurveda and Integrated Medical Sciences (JAIMS). 2017L 2. 10.21760/jaims.v2i3.8203.
- Ahir JA: A control clinical study of SuvarnaPrashana in Recurrent Upper Respiratory Infection in Children. Paripex Indian Journal of Research 2019; 7(12).
- Sushruta, Sushruta Samhita. Edited by Ambika Datta Shastri. 14th ed. Sharirasthana 10/15. Varanasi: Chowkhamba Sanskrit Series 2004.
- Vagbhata, Samgraha A, Tantra U and Adhyaya R: In: 1/8. 1st Shivprasad Sharma., editor. Varanasi: Chaukhambha Sanskrit Series Office 2006: 914.
- Vagbhata, Hridaya A, Sthana U and Adhyaya B: 1/9, 47 48, edited by Hari Shastri Paradkar, 9th Chaukhambha Orientalia, Varanasi 2002; 778-81.
- Vagbhata, Hridaya A, Sthana U and Adhyaya B: 1/9, 47 48, edited by Hari Shastri Paradkar, 9th Chaukhambha Orientalia, Varanasi 2002; 778-81.
- Sharangadhara, Samhita S and Khanda P: In: 6/27. 5th Murthy KR, editor. Varanasi: Chaukhambha Orientalia 2003: 29.
- Das G, Ratnavali B and Balarogachikitsa: In: 71/8. 19th Brhmashankar Tripathi., editor. Varanasi: Chaukhamba Prakashan; 2009: 1073.
- Kulkarni DA: editor. New Delhi: Meharchand Lachhmandas Publications; 1998. Vagbhata, Rasaratna Samuchaya, Vol. 1, 22/136; 13-6.
- Vridha J, Kashyapa S, Sutra S and Leha A: edited by Shri Satyapal Bhishagacharya, 10th Chaukhambha Sanskrit Sansthan, Varanasi, 2005; 4-5.
- Mitra A, Chakraborty S and Auddy B: Evaluation of chemical constituents and free-radical scavenging activity of Swarnabhasma (gold ash): an Ayurvedic drug. J Ethnopharmacol 2002; 80: 147-53.
- Sanjay Khedekar AP, Patgiri B, Nariya M and Prajapati PK: Immunomodulatory activity of Swarna Prashana in Charle’s Foster albino rats. J Ayurveda Med Sci 2016; 1(2): 6.
- Singh P, Pandit S, Mokkapati V, Garg A, Ravikumar V and Mijakovic I: Gold nanoparticles in diagnostics and therapeutics for human cancer. Int J Mol Sci 2018; 19(7).
- Villiers C, Freitas H, Couderc R, Villiers MB and Marche P: Analysis of toxicity of gold nano particles on the immune system: Effect on dendritic cell system functions J Nanopart Res Jan 2010; 12(1): 55-60.
- Brown CL, Bushell G, Whitehouse MW, Agrawal DS, Tupe SG, Paknikar KM and Tiekink ERT: Nanogold pharmaceutics. Gold Bull 40(3): 245–250.
- Senthilkumar S, Kashinath L, Ashok M and Rajendran A: Antibacterial properties and mechanism of gold nanoparticles obtained from Pergularia daemia Leaf Extract. J Nanomed Res 2017; 6(1): 00146.
- Sarjan HN, Divyashree S and Yajurvedi HN: The protective effect of the Vacha rhizome extract on chronic stress-induced immunodeficiency in rat. Pharmaceutical Biology 2017; 55(1), 1358-67.
- Parveen S, Taneja N, Bathi RJ and Deka AC: Evaluation of circulating immune complexes and serum immunoglobulins in oral cancer patients--a follow up study. Indian J Dent Res 2010; 21(1): 10-5.
- Varanasi: Chaukhambha Sanskrit Sansthan; 2009. Chakrapanidatta, Commentator. Charaka Samhita, Vimana Sthana, Rogabhishajitiya Adhyaya, 8/122, reprint Ed 280.
- Sharma V, Hiremath R, Patil A and Prasad B: Safety assessment on chronic administration of Swarna Bindu Prashana. Indian Journal of Experimental Biology; Vol;55,April 2017
- Patil A, Dindore sP, Aziz A, Kadam A and Saroch V: Clinical effect of suvarnabinduprashan. J Ayurveda Integr Med Sci 2017; 3: 11.
- Brown CL, Bushell G, Whitehouse MW, Agrawal DS, Tupe SG, Paknikar KM and Tiekink ERT: Nanogoldpharmaceutics. Gold Bull 2007; 40(3): 245-50.
- Mandal MD and Mandal S: Honey: its medicinal property and antibacterial activity. Asian PJTB 2011; 1: 154-60.
- Chinnadurai K, Kanwal HK, Tyagi AK, Stanton C and Ross P: High conjugated linoleic acid enriched ghee (clarified butter) increases the antioxidant and antiatherogenic potency in female Wistar rats. Lipids Health Dis 2013; 12: 121.
How to cite this article:
Pareek R and Ojha N: Evidence based study of effect of swarna yoga (gold formulations) in children: a systematic review. Int J Pharm Sci & Res 2021; 12(12): 1000-05. doi: 10.13040/IJPSR.0975-8232.12(12).1000-05.
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IJPSR
Rashmi Pareek * and Nisha Ojha
P.G. Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur, Rajasthan, India.
rashmi.pareek007@gmail.com
30 November 2020
03 May 2021
28 May 2021
10.13040/IJPSR.0975-8232.12(12).1000-05
01 December 2021