Mangaiarkarasi, P (2020) Phase II Open Comparative Nonrandomized Clinical Evaluation of Varmam Therapy and Siddha Drug Sirupanchamoola Kiyazham (Int), Thirumeni Ennai (Ext) in Saganavadam (Cervical Spondylosis) – Patients attending Varmam Department of Anna Hospital (Branch VIII - Varmam Maruthuvam). Masters thesis, Government Siddha Medical College, Chennai.
Full text not available from this repository.Abstract
The dissertation is a comparative study on safety and efficacy of “Varmam” therapy, Poly herbal drug “Sirupanchamoola Kiyazham” as internal medicine and “Thirumeni Ennai” as external medicine in Saganavadam. Cervical Spondylosis is correlated with Saganavadam. 60 cases with Saganavadam were diagnosed clinically based on Yugi Vaithyachinthamani and admitted in the inpatient ward and outpatient ward of post graduate department of Varmam Maruthuvam, GSMC attached with Aringar Anna Hospital for Indian Medicine and Homeopathy, Chennai - 106 and treated by the trial medicines. The Study Protocol was approved by Institutional Ethics committee (GSMC-CH-ME-5/011/2018). Before starting the clinical trial, was registered in Clinical Trials Registry of India and the reference number of the same is CTRI/2019/06/019695. Literature survey showed that the ingredients in trial drugs were found to have anti vatha, anti-inflammatory, anti-oxidant, analgesic, owing to the disease manifestations. Review data of diseases was collected by various Siddha literature. For standardization of trial drug, after getting Authentication, Qualitative and Quantitative Physico-chemical analysis were done by AYUSH guidelines, toxicological study of acute and sub-acute were done by OECD guide lines. From the Docking study the compound such as Solanine, quercetin, Lupeol and Luteolin present in the formulation Sirupanchamoola kiyazham possess significant binding against the target protein, so this formulation has promising analgesic and anti-arthritic activity. The trial Medicines were prepared from commonly available ingredients and the cost is affordable. The dosage was convenient as reported by the participants of the trial. Heavy metal content of Sirupanchamoola Kiyazham and Thirumeni Ennai were with in permitted limits. The acute & Sub acute toxicity study revealed that the trial drugs Sirupanchamoola Kiyazham is safe; Hence it can be concluded that the Siddha trial drug Sirupanchamoola Kiyazham is safe for human administration. In clinical study, Siddha methods of Envagai Thervu were used for diagnosis of the disease and relevant information were recorded in the prescribed Proforma for the Sixty selected cases. Laboratory investigations conducted regularly in all the patients before and after treatment and found to be correlated with the prognosis observed among the participants Statistical analysis helps to evaluate p-value significant in the pain score, safety parameters and efficacy of trial drug. The clinical trial proved the efficacy of the trial drugs by significantly reducing the clinical signs and symptoms like neck pain, stiffness, numbness and restricted movements. The clinical improvement was statistically significant. In Group I, treated with Varmam therapy alone, 85% of patients had Good improvement, 10% of patients had moderate improvement. 5% of the patients had Mild improvement.5% of the patient no improvement. In Group II, treated with Internal and external medicines, 65% of patients had Good improvement, 20% of patients had moderate and 10% mild improvement and 5% of patients had No improvement. In Group III, treated with medicines and Varmam therapy, 95% of patients had Good improvement, 5% of patients had moderate improvement. None of the patients showed Mild and No improvement. Group III had shown better results over the other two groups. These results revealed good outcomes from the disease after treatment. Here author proven the efficacy of drug. During the course of treatment there were no adverse effects or unwanted drug reactions in GIT, CVS, RS and Excretory systems. Hence it is concluded that the combined therapy of Varmam with Sirupanchamoola Kiyazham (internal) and Thirumeni Ennai (external) gives significant improvement in the treatment of Saganavadam (Cervical Spondylosis). Hence the study concludes that, the trial drugs and Varmam therapy were clinically effective in reduction of the symptoms of Cervical Spondylosis. It was best method of medication in comparative study and got primary and secondary objectives like efficacy and safety of trial drug.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 321718101 |
| Uncontrolled Keywords: | Phase II Open Comparative, Nonrandomized, Clinical, Evaluation, Varmam Therapy, Siddha Drug, Sirupanchamoola Kiyazham, Thirumeni Ennai, Saganavadam, Cervical Spondylosis. |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 23 Nov 2021 17:00 |
| Last Modified: | 23 Nov 2021 17:00 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/18632 |
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