Phase II Non Randomized Open Comparative Clinical Evaluation of Varmam and Siddha Trial Drugs Nilavaagai Kiyazham and Kaal Varma Thailam on Azhal Keel Vaayu (Osteoarthritis) in the Patient Attending OPD at Varmam Department of Aringner Anna Hospital (Branch VIII - Varmam Maruthuvam)

Nivetha, G (2020) Phase II Non Randomized Open Comparative Clinical Evaluation of Varmam and Siddha Trial Drugs Nilavaagai Kiyazham and Kaal Varma Thailam on Azhal Keel Vaayu (Osteoarthritis) in the Patient Attending OPD at Varmam Department of Aringner Anna Hospital (Branch VIII - Varmam Maruthuvam). Masters thesis, Government Siddha Medical College, Chennai.

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Abstract

The focus of the study was to evaluate the Efficacy of the SIDDHA VARMAM and siddha varmam trial drug NILAVAAGAI KIYAZHAM (internal) and KAAL VARMA THYLAM (external) experimentally and clinically in the management of AZHAL KEEL VAAYU (OSTEOARTHRITIS). This clinical study was carried out in Post Graduate OPD of Department of Varmam Maruthuvam, GSMC, Arignar Anna Hospital for Indian Medicine, Chennai-106 during the period 2018-2020. The Study population 60 and 20 patients were treated with Varmam, another 20 patients were treated with Nilavaagai kiyzham and Kaal varma thylam and remaining 20 patients were treated with Varmam along with Nilavaagai kiyzham and Kaal varma thylam. The duration of the treatment were 30 days. ❖ Females were mostly affected (63%). ❖ Most of the subjects were belongs to the age group of >50 yrs. ❖ Most of the subjects belongs to middle income group. ❖ This disease is more common in field work with physical labor (20%) ❖ Most of the subjects were vadha thegi (42%). ❖ In Vatham, Abanan (47%), Pranan (12%), Vyanan (100%), Samanan (100%), Koorman (32%), Kirugaran (15%), were affected. ❖ In Pitham, Analagam (27%), Ranjagam (32%), Sathagam (100%) and Alosagam (32%) were affected. ❖ In Kabham, Sandhigam (100%) were affected. ❖ In Ezhu udal thathukkal, Saaram (100%), Senneer (32%), Oon (100%), Koluppu (100%) and Enbu (100%) were affected. ❖ Among En Vagai thervugal, in Naadi vadham (25%) and pithavadham (25%) were seen predominantly. In Nei kuri vadha neer was predominantly seen. ❖ Sirattai varmam, Mootu varmam, Veeradangal, Mael mannai varmam, Viruthi kalam and Idamoorthi kalam were chosen for this study to measure its efficacy in managing osteoarthritis 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 Nilavaagai kiyazham (internal) and Kaal varma thylam (external) were also chosen to find out the efficacy in combined treatment. Physicochemical analysis, heavy metal analysis and toxicity study were conducted for standardisation of internal trial drug. ❖ The acute & Sub acute toxicity study reveals that the trial drugs Nilavaagai kiyazham is safe, 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 Nilavaagai kiyazham is safe in animal models. ❖ Heavy metal analysis of Nilavaagai kiyazham reveals that within permitted limit as per AYUSH guideline. ❖ Pharmacological study shows that the siddha varma trial drug Nilavaagai kiyazham possess anti-inflammatory activity. ❖ In blood parameter, reduction in CRP were noted after the intervention of siddha varmam trial drug NILAVAAGAI KIYAZHAM. ❖ Inferential analysis of Clinical features reveals that there was great improvement in symptoms like pain, swelling and stiffness. ❖ Statistical analysis of the clinical study reveals that the P value is <0.001and concluded that the treatment is effective and significant. ❖ No major adverse effect was reported during this clinical trial. In group I, 50% of the patients had Good improvement, 45% of them had moderate and only 5% of mild improvement and none of them had reported as no improvement. In group II, 25% of the patients had Good improvement, 55% of them had moderate and 20% 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 combinedly with varmam along with Nilavaagai kiyazham and Kaal varma thylam shows a significant improvement with symptomatic management in Osteoarthritis. From the 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 Nilavaagai kiyzham and Kaal varma thylam in the effective treatment of Azhal keel vaayu (Osteoarthritis). Further studies should be carried out in a larger population to standardize this treatment protocol for osteoarthritis. Likewise, more clinical trial needs to happen with other siddha varmam points and siddha varmam drugs.

Item Type: Thesis (Masters)
Additional Information: 321718102
Uncontrolled Keywords: Phase II Non-Randomized Open Comparative Clinical, Evaluation, Varmam, Siddha Trial Drugs, Nilavaagai Kiyazham, Kaal Varma Thailam, Azhal Keel Vaayu, Osteoarthritis.
Subjects: AYUSH > Maruthuvam
Depositing User: Subramani R
Date Deposited: 23 Nov 2021 16:51
Last Modified: 23 Nov 2021 16:52
URI: http://repository-tnmgrmu.ac.in/id/eprint/18631

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