Ruthra, K (2022) Phase II Non Randomized Comparative Open Clinical Evaluation on Puyavarmam Paathippu (Periarthritis Shoulder) treated with Varmam, Kurunthotti Kiyazham (Internal) and Kai Varma Ennai (External). Masters thesis, (Branch VIII - Varma Maruthuvam) Government Siddha Medical College, Chennai.
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Abstract
The clinical study on PUYAVARMAM PAATHIPPU (PERIARTHRITIS SHOULDER) to evaluate the therapeutic Efficacy of the VARMAM THERAPY and Siddha Varmam trial drug KURUNTHOTTI KIYAZHAM (internal) and KAIVARMA ENNAI (external) was done in the outpatient department of PG Varmam Maruthuvam, Government Siddha Medical College, attached to Arignar Anna Hospital for Indian Medicine, Chennai-106 during the period 2020-2021. The study protocol was approved by the Institutional Ethics committee (GSMC-CH-3401/ME-2/022/2019) and the trail was registered in Clinical Trails Registry India and the reference number is: CTRI/2021/04/032820. The toxicity studies were done to assess the safety and parameters of the trail drug, by IAEC Committee (IAEC No: IAEC/XLIV/12/CLBMCP/2021). Standardization and Quality Evaluation of the drug was done. The Study population 60 and 20 patients were treated with Varmam, another 20 patients were treated with Kurunthotti kiyazham (internal) and Kaivarma ennai (external) medication and remaining 20 patients were treated with Varmam along with Kurunthotti kiyazham and Kaivarma ennai. The duration of the treatment were 21 days. ❖ Females were mostly affected (60%). Most of the subjects were belongs to the age group of 51-60yrs. ❖ Most of the subjects belongs to middle income group (55%). ❖ This disease is more common in home maker and physical labour. ❖ Most of the subjects were vadha thegi (47%). ❖ In Vatham, Pranan (18%), abanan (30%), samanan (100%), vyanan (100%), devathathan (22%) were affected. ❖ In Pitham, analagam (25%), ranjagam (10%), Sathagam (100%), were affected. ❖ In Kabham, Santhigam (100%), Avalambagam (100%) were affected. ❖ Among seven udal thathukkal, saaram (15%), senneer (16.6%), Oon (67%), koluppu (53%), enbu (100%), were affected. ❖ Among En Vagai thervugal, in Naadi vadhapitham (62%) and pithavadham (27%) were seen predominantly. ❖ In Nei kuri vadha neer (61.6%) was predominantly seen. ❖ Kaakattai kaalam, Aenthi Varmam, Piratharai Varmam, Sippi Varmam, Sippikeezh Varmam, Kaisulikki Varmam, Kai mootu and moothu padhappu, Kozhi kalunthu Varmam, Mani bandhaga Varmam, Manjaadi kaalam varmam were chosen for this study to measure its efficacy in managing Puyavarmam paathippu (Periarthritis shoulder) and to standardize the location and manipulation techniques of the varmam points were analysed as per siddha varmam book. ❖ Along with Varmam, Siddha varmam trial drug Kurunthotti kiyazham (internal) and Kaivarma ennai (external) were also chosen to find out the efficacy in combined treatment. ❖ Physicochemical analysis, heavy metal analysis and toxicity study were conducted for standardization of internal trial drug. ❖ The acute & Sub acute toxicity study reveals that the trial drug Kurunthpotti kiyazham is safe and had no lethal or any adverse effect. Sub acute toxicity study two doses were administrated orally for 28 days. Animals were observed for physiological and behavioural changes food and water, intake body, weight, mortality. No mortality was observed, and no treatment related changes seen. Hence the Siddha Varmam trial drugs Kurunthotti iyazham is safe in animal models. ❖ Heavy metal analysis of Kurunthotti kiyazham reveals that within permitted limit as per AYUSH guideline. ❖ Pharmacological study shows that the Siddha Varmam trial drug Kurunthotti kiyazham possess anti-inflammatory activity and Analgesic activity. ❖ Inferential analysis of Clinical features reveals that there was great improvement in symptoms like pain, stiffness, radiating pain and restriction of movements. ❖ Statistical analysis of the clinical study reveals that the P value is <0.001 and concluded that the treatment is effective and significant. ❖ No major adverse effect was reported during this clinical trial. OUTCOME OF THE CLINICAL ASSESSMENTS: In group I, 80% of the patients had Good improvement, 15% of them had moderate and only 5% of mild improvement. In group II, 70% of the patients had Good improvement, 15% of them had moderate and 15% had mild improvement and none of them had reported as no improvement. In group I, 90% of the patients had Good improvement, 10% of them had moderate and none of them had reported as mild or no improvement. Among three groups the group treated with Varmam along with Kurunthotti kiyazham and Kaivarma ennai (GROUP III) shows a significant improvement with symptomatic management in Periarthritis shoulder. CONCLUSION : From these findings, I conclude that Siddha Varmam is a cost effective, safe and non - invasive therapy which gives better result when combined with siddha varmam trial drug Kurunthotti kiyazham (internal) and Kaivarma ennai (external) in the effective treatment of Puyavarmam paathippu (Periarthritis shoulder). Further studies should be carried out in a larger population to standardize this treatment protocol for Periarthritis shoulder. Likewise, more clinical trial needs to happen with other siddha varmam points and siddha varmam drugs.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No: 321918101 |
| Uncontrolled Keywords: | Phase II Non Randomized Comparative Open Clinical Evaluation, Puyavarmam Paathippu, Periarthritis Shoulder, treatment, Varmam, Kurunthotti Kiyazham, Kai Varma Ennai. |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 10 May 2023 04:51 |
| Last Modified: | 24 Feb 2024 12:42 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21252 |
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