A clinical study to evaluate the safety and efficacy of pachai karpoora vadagam (Internal medicine) and vaeppa ennai (External medicine) on Azhal Keel Vayu (Osteoarthritis)

An open clinical trial conducted to access the safety and efficacy of Pachai Karpoora Vadagam (PKV) and Vaeppa Ennai (VE) in the management of Azhal Keel Vayu (AKV) is one among 10 types of Keel Vayu diseases particularly occurring in joints. The trial was conducted at OPD/IPD of Ayothidoss Pandithar Hospital, in accordance with the standard study protocol duly approved by the Institutional Ethics Committee (IEC) of National Institute of Siddha. The clinical study is registered in Clinical Trials Registry - India. Duly signed informed consent was obtained from every patient before trial enrollment. Among 40 subjects, 20 subjects were treated on OPD basis and remaining 20 subjects were admitted in IPD for 48 days. Trial subjects were screened and documented by the standard screening proforma. Universal pain assessment scale was used to assess the trial outcome. Clinical assessment was done on every 7th day and prognosis was noted in the prescribed proforma, daily in IPD subjects. Paired‘t’ test was used to test the significance of treatment. The study revealed statistical significance of pain score before and after treatment of Pachai Karpoora Vadagam (PKV) and Vaeppa Ennai (VE) (p <0.001). There are no significant statistical changes of safety parameters such as Liver Function Test and Renal Function Test before and after treatment. Hence it is concluded that the drugs are safe and effective in the management of AKV (Osteoarthritis).