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| ORIGINAL ARTICLE |
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| Year : 2020 | Volume
: 7
| Issue : 1 | Page : 20-26 |
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A Placebo-controlled Clinical Evaluation of Gokshuradi Taila Matravasti in the Management of Gridhrasi vata (Sciatica)
Abhishek Bhattacharjee
Department of Panchakarma, College of Ayurveda, North Eastern Institute of Ayurveda and Homoeopathy, Shillong, Meghalaya, India
| Date of Submission | 24-Jan-2021 |
| Date of Decision | 13-Feb-2021 |
| Date of Acceptance | 01-Mar-2021 |
| Date of Web Publication | 09-Jul-2021 |
Correspondence Address:
Dr. Abhishek Bhattacharjee
Department of Panchakarma, College of Ayurveda, North Eastern Institute of Ayurveda and Homoeopathy, Mawdiangdiang, Shillong, Meghalaya
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/AYUHOM.AYUHOM_11_21
Background: Gridhrasi is one of the Vataja Nanatmaja diseases which we commonly come across in our clinical practice. A radiating pain starting from the lower back up to the foot is the cardinal feature often associated with stiffness, pricking, and tingling sensation which are very similar to the symptoms of sciatica. Gokshuradi Taila Matravasti is indicated for Gridhrasi in Vangasena Samhita. Aim and Objective: Placebo-controlled clinical evaluation of Gokshuradi Taila Matravasti in the patients of Gridhrasi (sciatica). Materials and Methods: A single-blind, placebo-controlled clinical study was conducted with pretest and posttest design where 60 patients suffering from Gridhrasi (sciatica) were selected and randomly allocated into two groups (Group-A and Group-B) after initial screening. The patients of Group-A were treated with Gokshuradi Taila Matravasti and Group-B with rectal administration of specially designed placebo drug for 14 days. Patients were observed for a total follow-up period of 30 days with three stages of assessment on 0, 15th, and 30th day. The assessment of results was made by adopting the standard methods of international scoring including pain, neurological deficit, functional ability, functional disability, and also selective signs and symptoms. Statistically significant test for comparison was done by ANOVA followed by Tukey's multiple comparison test. Results: Statistically significant relief was observed in the patients of Group-A, treated with Gokshuradi Taila Matravasti compared to Group-B (control group) at the end of the study.
Keywords: Gokshuradi Taila, Gridhrasi, Matravasti, sciatica
How to cite this article:
Bhattacharjee A. A Placebo-controlled Clinical Evaluation of Gokshuradi Taila Matravasti in the Management of Gridhrasi vata (Sciatica). AYUHOM 2020;7:20-6 |
How to cite this URL:
Bhattacharjee A. A Placebo-controlled Clinical Evaluation of Gokshuradi Taila Matravasti in the Management of Gridhrasi vata (Sciatica). AYUHOM [serial online] 2020 [cited 2023 Mar 31];7:20-6. Available from: http://www.ayuhom.com/text.asp?2020/7/1/20/320923 |
| Introduction | |  |
Ayurveda is one of the most ancient medical sciences of the world dedicated for the promotion of health, prevention, and cure of disease since time immemorial.[1] According to Ayurveda, simple freedom from the diseases cannot be considered as health. For being healthy, an individual's doshas should be in a normal functional state, digestive and metabolic functions should be normally carried out, body tissues should be in optimum level along with this his sense faculties, and mind and soul should be in a fully functional and cheerful state.[2],[3] Disruption or imbalance in the equilibrium of doshas (Vata, Pitta, and Kapha) is termed as Vikara or disease.[4] Among three doshas, Vata is considered to be responsible for all sensory and motor functions.[5] All ayurvedic scholars have given due importance to Vata as the prime regulator of various physiological and pathological activities of the body and the most important factor in causing disease.[6] The disease Gridhrasi mentioned in most of the ancient ayurvedic texts is very much similar to that of sciatica mentioned in modern contemporary system of medicine and is considered as one of the Vataja Nanatmaja disorders.[7] This condition is commonly seen in clinical practice and the incidence is expected to be increasing through the coming years due to erroneous diet habits, faulty postures, lack of physical exercise, sleep disturbances, and mental stress. The cardinal features of Gridhrasi are pain, pricking sensation, stiffness, and repeated twitching observed in the buttocks, low back, thigh, back of knee, calf region, and foot[8] with restricted lifting of the affected leg.[9]
Change in the lifestyle of stressful and competitive modern man has created disharmony in his biological system. Busy professional and social life, improper posture, continuous strenuous work, over exertion, and jerky movements during travel and sports create biodynamic changes in the weight-bearing spinal column. This may cause variety of pain causing spinal disorders. Among them, the most common disorder which affects the movement particularly in the most productive period of life is low back pain, out of which 40% of patients develop radicular pain, which is considered as sciatica. Sciatica is a condition where pain begins in the low back and radiates along with the distribution of sciatic nerve, i.e., the posterolateral aspect of thigh and leg up to foot.[10] In this condition, the patient generally develops difficulty in walking along with sensory and motor deficits in the long run. Degenerative changes in the intervertebral discs resulting in herniation of one or more degenerated disc causing compression over the lumbosacral nerve roots are the most common cause.[11] There is often history of trauma, lifting of heavy objects, prolonged working in forward bending position, and continuous standing postures, yet in many of the cases the actual causative factor remains unknown.
In modern contemporary medicine, conservative remedies such as use of analgesics, physiotherapy, epidural infiltrations, computed tomography (CT)-guided periradicular infiltrations, and surgical procedures to decompress the spinal nerve roots are the options available. Treatment is not affordable many a times for the poor patients, and symptoms often recur even after treatment in the long run. On the other hand, ayurvedic classics have described schedule of treatment for Gridhrasi with simple drugs, diet, Panchakarma, and parasurgical procedures. Some of them are proved to be effective by clinical trials. Many studies suggest Vastikarma (colorectal administration of drug) more effective when compared to other procedures in the management of Gridhrasi.
Hence, the present study was planned to conduct a placebo-controlled clinical evaluation of Gokshuradi Taila Matravasti in the management of Gridhrasi (sciatica). Any work done with placebo-controlled study is a valid area of research. Hence, a placebo model of Vasti was developed for the control group to ascertain the real therapeutic effect of selected Vasti formula.
| Materials and Methods | | |
Materials
Gokshuradi taila
Gokshuradi Taila mentioned in Vatavyadhi Adhikara of Vangasena Samhita[12] was taken for Matravasti. The oil contains five simple ingredients with Vata pacifying property. The ingredients with proportion are shown in [Table 1].
Placebo drug
The placebo drug for rectal administration was prepared with starch powder 10 g mixing with 60 ml of distilled water. Edible permitted food color was added to create the same color like the trial medicine.
Methods
Source of data
The patients were screened and randomly allocated into two groups with 30 patients in each group, i.e., Group-A (trial group) and Group-B (placebo control) after fulfilling the inclusion and exclusion criteria. Written informed consent was taken from patients after offering sufficient explanations about the study and its aims. Data of every patient including their personal details, clinical details, and therapeutical details were noted down in a specially designed pro forma.
Inclusion criteria
- Age between18 and 60 years
- Low back pain radiating to lower limb
- Patients who are willing to participate in the study and ready to give written consent.
Exclusion criteria
Diabetes mellitus, severe metabolic disorders, hypertension, psychiatric disorder, Pott's spine, space-occupying lesions of the spinal cord, malignancy, postspinal surgical cases, epilepsy, and all other diseases that need regular medication.
Investigations
Hemogram, fasting and postprandial blood sugar, glycosylated hemoglobin, renal function test, liver function test, fasting lipid profile, routine and microscopic examination of urine and stool, and CT scan/magnetic resonance imaging of the lumbosacral spine were carried out before treatment to exclude other conditions.
Intervention
In Group-A, Matravasti of Gokshuradi Taila (60 ml) was administered for 14 days uninterruptedly, and in Group-B, rectal administration of the placebo drug was carried out for 14 days uninterruptedly.
Assessment criteria
Patients were observed for 30 days. Assessment was done initially on “0” day, i.e., before the medical intervention and on 15th and finally on the 30th days. Parameters of assessment were based on the classical symptoms mentioned for Gridhrasi, angle of straight leg raise test (SLRT), and following quality of life (QoL) scoring methods: (1) Aberdeen Low Back Pain Disability Scale and (2) Modified Oswestry Low Back Pain Disability Questionnaire. Objective measures do not always correlate with subjective experiences.[13],[14] Here, to assess the functional impact of sciatica and the effect of treatment on patients, these valid QoL scores[15],[16] were used.
Statistical analysis:
Statistically significant test for comparison was done by ANOVA, followed by Tukey's multiple comparison test. GraphPad Instat software was used for statistical analysis (California corporation, San Diego).
| Results | | |
The assessment of results was made by adopting the standard international scoring methods. This includes the assessment of pain, neurological deficit, functional ability, and functional disability along with signs and symptoms.
Effect of placebo and Matravasti on Ruk (pain)
The relief of pain in Group-A on the 15th as well as 30th days was extremely significant. In the patients of Group-B, significant reduction of pain was observed on the 15th day, whereas on the 30th day, relief of pain was not significant in comparison with 0th day [Table 2], [Table 3] and [Graph 1].
Effect of placebo and Matravasti on Toda (pricking sensation)
The relief of Toda in Group-A on the 15th day is highly significant and the intensity of Toda on the 30th day in comparison with Toda intensity on the 0th day is extremely significant. In Group-B, on 15th day as well as on 30th day, there is no significant relief in Toda [Table 4], [Table 5] and [Graph 2].
Effect of placebo and Matravasti on Stambha (stiffness)
The relief of Stambha in Group-A on the 15th day as well as 30th day was extremely significant. On the other hand, in case of Group-B, assessment on 15th day as well as on 30th day did not show significant reduction of stambha [Table 6], [Table 7] and [Graph 3].
Effect of placebo and Matravasti on Spandana (twitching)
In Group-A, on the 15th day, the reduction in Spandana was significant and on 30th day highly significant improvement was observed. On the other hand, the placebo Vasti did not show any significant effect on the intensity of Spandana on 15th or 30th day [Table 8], [Table 9] and [Graph 4].
Effect of placebo and Matravasti on strait leg raising test
On the 15th day and during the follow-up on 30th day, extremely significant improvement in SLRT was observed in Group-A. On the other hand, in Group-B, though significant improvement was observed on 15th day, SLRT evaluated on 30th day did not show statistically significant difference compared to 0thday [Table 10], [Table 11] and [Graph 5]. | Table 10: Effect of placebo and Matravasti on strait leg raising test on 15th day
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 | Table 11: Effect of placebo and Matravasti on strait leg raising test on 30th day
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Effect of placebo and Matravasti on “modified Oswestry Low Back Pain and Disability Questionnaire” score
In Group-A, extremely significant improvement was seen in the score of ”Modified Oswestry Low Back Pain and Disability Questionnaire;” on the contrary, in Group-B, no significant improvement was observed [Table 12], [Table 13] and [Graph 6]. | Table 12: Effect of placebo and Matravasti in terms of “Modified Oswestry LOW back Pain and Disability Questionnaire” score on 15th day
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 | Table 13: Effect of placebo and Matravasti in terms of “Modified Oswestry Low Back Pain and Disability Questionnaire” score on 30th day
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Effect of placebo and Matravasti on “Aberdeen Low Back Pain Scale”
In Group-A, extremely significant improvement was observed in terms of “Aberdeen Low Back Pain Scale” score on both 15th day and 30th day. On the other hand, significant reduction of the score was observed on 15th day, but on 30th day, the reduction of “Aberdeen Low Back Pain Scale” score in Group-B was not found to be significant [Table 14], [Table 15] and [Graph 7]. | Table 14: Effect of placebo and Matravasti on “Aberdeen Low Back Pain Scale” on 15th day
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 | Table 15: Effect of placebo and Matravasti on “Aberdeen Low Back Pain Scale” on 30th day
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| Discussion | | |
As Gridhrasi is one of the Nanatmaja Vatavyadhis, the main involved dosha is Vata and among the five varieties, Vyana Vayu, which is responsible for all motor activities, is considered to be mainly vitiated in case of Gridhrasi. The aggravated Vata takes shelter in Sira, Snayu, Kandara and the nearby structures in the lower limb and vitiates them. As a result, the person develops Stambha, Ruk, Toda, Graha, and Spandana, which starts in the Sphik and gradually radiates up to Pada.
As Taila is the best Samana aushadhi and Vasti is the best Shodhana aushadhi for vitiated Vata, oil administered as Vasti is preferentially the best line of treatment in Vata disorders. As Pakvashaya is the main site of Vata, so when oil prepared with Vata-hara drugs is administered directly to Pakvashaya in the form of Matravasti, normalizes Vata functions in the whole body.
Gokshuradi Taila contains five ingredients, all of which are easily available and cost-effective. The properties of the ingredients of Gokshuradi Taila are shown in [Table 16].
Sushruta has stated that the actions of Vasti are mainly due to Virya, i.e., specific action or property of the Vasti dravyas. In this study, Tila taila which is having Sukshma, Vyavayi, and Vikasi guna is used as the base of the drug, as a result the active principles (Virya) of the drug spreads very fast all over the body through the minute srotas when administered as Vasti. In [Table 16], the properties and specific dosha hara actions of the ingredients of Gokshuradi taila used for Matravasti are shown, which indicates the predominant Vatahara action of the oil.
| Conclusion | | |
Gokshuradi Taila (mentioned in Vatavyadhi adhikara of Vangasena Samhita) was selected for Matravasti in the present study to evaluate its efficacy in the management of Gridhrasi. The observations and results were analyzed statistically and significant improvements were found in the patients getting Gokshuradi Taila Matravasti in comparison to Placebo. No significant adverse effect was noticed in any patient during the study period.
Acknowledgement
I would like to express my special gratitude and regards to my teacher Dr. P. Murali Krishna, Professor, Department of Panchakarma, S. V. Ayurvedic College, Tirupati for his Guidance and support.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 15], [Table 16]
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