EVALUATION OF EFFICACY OF UNANI REGIMEN IN THE REHABILITATION OF POST STROKE HEMIPLEGIC GAIT: AN OPEN INTERVENTIONAL STUDY

EVALUATION OF EFFICACY OF UNANI REGIMEN IN THE REHABILITATION OF POST STROKE HEMIPLEGIC GAIT: AN OPEN INTERVENTIONAL STUDY

S. Javed Ali * and Abdul Nasir Ansari

Department of Moalejat, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

ABSTRACT: Background: Stroke is the most frequent clinical manifestation of diseases of the cerebral blood vessels. Up to 90% of post-stroke survivors report one or more disabilities, including impaired walking. Physical rehabilitation and gait training with equipments are essential in the management of post stroke gait disability, however, these techniques are not amenable for hemiplegic patients because of their limitations to actively participate in such training programs. Unani (Greco-Arab) Medicine scholars have been known to treat post-stroke complications on concept of Tanqiya (elimination of morbid matter) and Ta’deel (revitalization of diseased organ) since centuries. Methods: The study was conducted as open, interventional clinical trial, enrolling 30 eligible patients. Tanqiya was done by Mundij (coctives) and Mus’hile Balgham (phlegm purgatives) drugs used in decoction form for 13 days; after Tanqiya, full body Inkibab (steam bath) with Advia Harrah (Hot temperament Drugs) was started from 14^th to 28^th day of the study for the purpose of Ta’deel. Assessment for gait improvement was performed on valid and reliable scale “FAC” at baseline, 14^th day and 28^th day of the treatment. Results: Significant statistical difference was observed in walking patterns between baseline and 14^th day scores (p<0.01); and base line and 28^th day scores (p<0.001) using Friedman test with Dunn’s multiple comparison test. No significant adverse change appeared in safety parameters. Conclusion: The test formulations, used in consonance with the concept of Tanqiya and Tadeel, were found effective and more feasible in the rehabilitation of post-stroke hemiplegic gait.

Keywords: Stroke, Hemiplegic gait, Neuroplasticity, Neuroprotection, Unani Medicine

INTRODUCTION: Stroke is one of the leading causes of mortality and morbidity worldwide. Up to 90% of stroke survivors report one or more disabilities ¹ of which, walking impairment is most commonly reported. ² Gait recovery is a major objective in the rehabilitation of patients of stroke ^{3, 4}.

The approaches used in gait rehabilitation after stroke include neurophysiological and motor learning techniques, robotic devices, FES (Functional Electrical Stimulation) and BCIs (Brain Computer Interfaces) ⁵. But the aforesaid techniques are not fully suited for hemiplegic patients because of their limitations to actively participate in such training programs ^{1, 6}.

According to concept of Unani (Greco-Arab) System of Medicine, Falij (Hemiplegia) is considered as a disease due to Sue Mizaj Balghami (Disease caused by derangement in phlegm). Sue Mizaj Maddi (including Balghami) is treated by Tanqiya (elimination of causative matter) and Ta’deel (revitalization of temperament). Tanqiya or Istifraghe Mawad is achieved by using drugs called as Mundij Advia which have properties such as Tahleel, Taqtee, and Talteef, followed by another set of drugs called as Mushil Advia which have propensity to expel the morbid Akhlat from whole body, particularly from vessels and neighboring structures through intestine. Ta’deel or Islahe Mizaj of affected Uzw (organ), which has been disturbed by causative matter is achieved by Muqawwie drugs and/or employing various Tadabeer (regimens) such as Dalk (massage), Riyazat (exercise), Takmeed (Hot Fomentation), Hammam (Hot Bath), Inkibab (steam bath) etc ^{7, 8, 9, 10, 11} . The combination of Tanqia and Tadeel constructs a comprehensive treatment line for Falij and mandates to be tested as such to evaluate the efficacy of employable intervention in its treatment of stroke related walking disability, scientifically.

METHODOLOGY: The study was conducted at National Institute of Unani Medicine (NIUM) hospital. Before starting the clinical trial, a comprehensive protocol was planned and put forth for ethical clearance from the Institutional Ethical Committee of National Institute of Unani Medicine, Bangalore. After ethical clearance (IEC Reference No: NIUM/IEC/2011-12/004/Moal) clinical study was conducted according to the Declaration of Helsinki and the GCP guidelines by enrolling eligible patients according to inclusion criteria. This study spanned for one year i.e. from February 2012 to January 2013.

The study was designed as open interventional clinical trial. A total of 30 patients were enrolled; 28 completed the trial with 2 drop outs due to unknown reasons. Fig. 1 the ingredients of Mundije Balgham, Mus’hile Balgham and Inkibab Table 13 were provided by pharmacy of NIUM. Proper identification of these drugs was done by chief pharmacist, NIUM, to ensure their originality and authenticity.

The ingredients of Mundije Balgham ^{12, 13} were pounded and soaked in 500 ml. of water for whole night. Joshanda (decoction) was prepared in the morning on low flame as per the standard procedure, and given to the patients to drink once in the morning before breakfast for 12 days. On 13^th day, the ingredients of Mus’hile Balgham were added in those of Mundije Balgham; Joshanda was prepared and given to drink in the morning before breakfast for one day only. On 14^th day, whole body Inkibab was started with Advia Harrah (hot temperament drugs), once a day for 20 minutes, for a period of 15 days i.e. up to 28^th day of test treatment. The drugs for Inkibab were soaked in 1.5 litre of water at night and boiled next morning; the generated steam was passed through a hose into steam chamber for the purpose of Inkibab of the patient sitting in the chamber.

Criteria for Selection of Cases:

Inclusion Criteria:

1. Post stroke gait disability
2. Patients aged between 18–64 years
3. Ischemic Stroke having history at least of 3 months
4. Either gender

Exclusion Criteria:

1. Patients with terminal medical conditions such as Cancer.
2. Unstable cardiac diseases.
3. Uncontrolled hypertension.
4. Renal insufficiency.
5. Pregnant and lactating women.
6. Other significant lower limb impairment e.g. fracture within six months.
7. Severe arthritis and amputation.
8. Evidence of fixed contracture.
9. Other diagnoses which may contribute to gait disorder e.g. bony deformities.
10. Cerebral palsy.
11. Patients who fail to give consent.
12. Medical conditions, where Inkibab is contraindicated.

Investigations: Following investigations were done to exclude other patients as a part of exclusion criteria; and to establish the safety of the test drug - Hb%, TLC, DLC, ESR, Blood Sugar-F/PP, RFT, LFT, Urine- R/M and ECG.

Test Drug:

TABLE 1: THE INGREDIENTS OF MUNDIJ BALGHAM

TABLE 2: THE INGREDIENTS OF MUS’HILE BALGHAM

TABLE 3: THE INGREDIENTS OF DRUGS FOR INKIBAB

Assessment: The assessment of efficacy of treatment was carried out on the basis of a valid and reliable scale- “FAC (Functional ambulation category)”, specific for walking ¹⁴. After 28 days of the treatment, Pre and post treatment values of FAC were subjected to statistical analysis using Friedman test with Dunn’s multiple comparison tests. Safety parameters were analyzed using paired ‘t’ test to assess statistical differences. Statistical analyses were carried out using Graph Prism 5.03. Difference was considered significant at P<0.05, highly significant at p<0.01.

FIG. 1: FLOW CHART OF STUDY PATIENTS

RESULTS: All patients (n=28) were associated with one or more risk factors of stroke i.e. Smoking, DM, HTN & Alcoholism. Demographic data is depicted by Table 4 (a) & 4 (b) and Fig. 2 & 3. The study outcome on Functional Ambulatory Categories at baseline, 14^th day and 28^th day of treatment was assessed using Friedman test with Dunn’s multiple comparison tests. Baseline and 28^th day comparisons were statistically significant (p<0.001). Baseline and 14^th day comparisons were statistically significant (p<0.01). Fig. 4 Safety parameters were assessed applying paired ‘t’ test using Graph pad prism 5.03.

Table 4(A):

TABLE 4(B):

FIG. 2: DISTRIBUTION OF PATIENTS ACCORDING TO INDIVIDUAL RISK FACTORES (N=28)                  

FIG. 3: DISTRIBUTION OF PATIENTS ACCORDING TO AGE (N=22)

FIG. 4: SAFETY PARAMETERS

DISCUSSION: According to tenets of Unani Medicine, Falij is considered as a disease due to Sue Mizaj Balghami (Disease caused by derangement in phlegmatic humour). Sue Mizaj Balghami is managed by Tanqiya (elimination of causative matter) and Ta’deel (restoration of temperament). Mundij Advia are endowed with properties such as Tahleel (dissolution), Taqtee(remotion) and Talteef,(demulcent), Mufattih (deobstruent) ^{9, 10} making the pivot for the first phase of Tanqia, which largely resembles with the current principle of treatment of stroke in modern medicine, advocating the use of thrombolytics, antithrombotic agents and neuroprotective drugs ¹⁵.

The drugs having property of Tahleel (dissolution) are known as Muhallil. They act on viscid humour to make it dissoluble and detachable from its site of pathology ⁹. Dawae Lateef has the property of Talteef and interacts with body’s Quwa Tabi‘iyya (natural faculties.) to divide the morbid matter into smaller parts ⁹. Muqatte advia are the drugs, which owing to property of Taqtee (remotion), penetrate into the interstitial spaces of the organs due to their lightness and remove the adhered khilt (humour) from the organ ⁹. The ingredients of the Mundije Balgham possess the above mentioned properties along with other synergistic properties such as Mufattih Sudad (deobstruent for blockages), Muharrik Dimagh(brain stimulants), Muqawwie Aa’saab (Nervine tonic), Muharrik-i-A‘sab (nervine stimulants), Jali (detergent) etc. and are; therefore, used in diseases such as Falij (Hemiplegia), Laqwa (Facial Palsy), and other Balghami Amraz (phlegmatic Disease) of nervous Sysytem ^{9, 16}. Once, the Ghair Mo’tadil Balghami madda (morbid phlegmatic material) is dissolved and broken down by the action of Mundije Balgham, it is purgated out by Mus’hilie Balgham. Mus’hil drugs have properties to expel the morbid Akhlat from the vessels, neighbouring structures and from whole body through intestine.

Majority of the Unani physicians believe that Mus’hil drugs expel both Raqeeq (thin) and Ghaleez (Viscous) constituents of Ghair Mo’tadil Akhlat (morbid humour), ¹⁷ which they have affinity with. The ingredients of Mus’hile Balgham have affinity with Balgham and; therefore, purge it out. After a course of Mus’hil, the remnant Buroodat (Coldness) diffused in Aa’saab is removed by Inkibab, using Haar Advia (hot temperament drugs). Inkibab (steam bath) itself produces Hararat (Hotness) and thereby used as Mufattih Sudad (deobstruent of blockages), Musakhkhin (calorific), and Muhallil (resolvent) ¹⁸. Inkibab with Haar Advia further helps to remove Buroodat caused by Balgham. The drugs used for Inkibab in this study possess properties such as Musakhkhin(calorific), Qaate wa mukhrije balgham (phlegm removal), Mu’arriq Muqawwie asab (Nervine Tonic), Musakkin (Pain removal), Mulattif (demulcent), Mufattih (deobstruent), Muqawwie Dimagh (Brain Tonic),^{12, 16, 19, 20} and therefore, are used in Falij and other Barid amraze asab ^{12, 16, 19, 20}.

Study by Nakayama H. suggested that maximum recovery was achieved by 95% of patients within 9 weeks of post stroke attack. The extent of recovery is highly dependent on the severity of initial deficit ²¹. The rehabilitation programs for post stroke individuals mainly focus on gait training ²². The techniques are aimed to generate adaptive reversibility in functions and structures of the undamaged brain and training is accomplished with that as the main objective. However, there are limitations to the ability of hemiplegic patients with damaged mobility to actively participate in such training programs, and it is not easy to activate the brain through sensory and kinesthetic stimulation to revive the neuroplasticity ^{6, 23}.

It is considered that the chief pattern of retrieval after stroke is decided by certain obscure biological processes, called as ‘spontaneous neurological recovery’ ²⁴. But till present-day the nature of this neurological recovery is not understood clearly ²⁵. Neuroplasticity has been reported as the ability of the brain to reorganize itself and form fresh neuronal connections throughout life ²⁶ and Neuroprotection is a concept of providing a treatment that sustains brain tissue tolerance to defy ischemia ¹⁵. It is achieved by prevention of oxidative stress, dysfunction in mitochondria, inflammation and cellular apoptosis in brain tissue ²⁷. Confining neuronal damage in the surrounding penumbra is a major goal for acute therapeutic interventions in post stroke patients. As described earlier, test formulations possess Muhallil, Mulattif, Mufatteh Sudad, Munaqqie Dimagh, Jali and Muhallile Auram properties, which ^{9, 12, 16} tend to open the obstruction and recanalise the vessels, scale down the inflammatory reaction and edema, reduce the damage of ischemic penumbra, and ultimately limit the neuronal damage by cumulative action of all the properties of test drugs. Recent studies also suggest that the Glycyrrhiza glabra ²⁸ and Pimpinella anisum ²⁹, used in this study are known to have neuroprotective activities and useful in decreasing infarct volume while others have antioxidant activities viz. Glycyrrhiza glabra, ³⁰ Paeonia emodi, ³¹ Trigonella foenumgraecum, ³² Rosa damascene, ³³ Operculia turpethom ³⁴ and Cassia fistula ³⁵. In the same manner antithrombotic activities were found in Essential oil of Foeniculum vulgare ⁵⁵ and anti-inflammatory activities in Paeonia emodi ³¹.  Experimental studies also revealed that spasmolytic or antispasmodic activities are present in Lavandula stoechas, Pimpinella anisum, Trigonella foenum-graecum, Matricaria chamomilla, Apium graveolens, Peucedanum graveolus, Paeonia emodi and Borago officinalis ^{32, 37, 38, 39, 40, 41, 42, 43}.

No major adverse effect was observed in any patient; only 2 patients complained of mild pain in abdomen after Mus’hil drugs, which were relieved by it after few hours. No adverse reaction was observed in any patient after Mundij and Inkibab therapy.

Futher, it has been observed in the study that almost all patients observed improvement in motor power and  ADLs, relaxation in spasticity of limbs which further reavalidates the observations of Ahmed et al (2015) ⁴⁴ and Yasir et al (2013) ⁴⁵. All patients were satisfied by unani regimen and were willing to enroll again in the study if needed.

CONCLUSION: It may be concluded from the above discussion that this study regimen is more feasible, safer and less expensive in comparison to modern techniques of hemiplegic gait improvement in post- stroke survivors. However large scale clinical trials with standard control are needed to infer more accurately.

ACKNOWLEDGEMENT: Authors are thankful to Physiotherapist, Nursing and IBT staff of NIUM hospital, Bangalore.

CONFLICT OF INTEREST: None

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    How to cite this article:

    Ali SJ and Ansari AN: Evaluation of efficacy of Unani regimen in the rehabilitation of post stroke hemiplegic gait: an open interventional study. Int J Pharm Sci & Res 2023; 14(10): 4871-77. doi: 10.13040/IJPSR.0975-8232.14(10).4871-77.

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