A Prospective,open labelled, single arm,non randomized, single centric,phase II,clinical trial to determine the effectiveness of parangipattai chooranam in the management of azhal keel vaayu (osteoarthritis of knee)

This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF PARANGIPATTAI CHOORANAM IN THE MANAGEMENT OF AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The trial drug PARANGIPATTAI CHOORANAM  is freshly prepared and will be administered at the dosage of 1 to 3 gms ( Twice a day orally) with milk (pasum paal) as adjuvant for 48 days for 40 osteoarthritis of knee patients ( 20 OP & 20 IP patients). The primary outcome will be determining the effectiveness of PARANGIPATTAI CHOORANAM (INTERNAL) in the management of AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The secondary outcome will be to collect various Siddha literatures and modern journals for literature review on AZHAL KEEL VAAYU, to study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, to perform physicochemical, phytochemical, bio chemical analysis of PARANGIPATTAI CHOORANAM, to evaluate safety profile for acute and sub-acute toxicity of -PARANGIPATTAI CHOORANAM, to evaluate pharmacological activities of PARANGIPATTAI CHOORANAM, to study about the prevalence of AZHAL KEEL VAAYU in relation with diet and lifestyle, to evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in AZHAL KEEL VAAYU during trial period, to evaluate DHEGI of AZHAL KEEL VAAYU patients, to evaluate modern parametric changes in AZHAL KEEL VAAYU, to assess the quality of life (QOL) of AZHAL KEEL VAAYU patients and to document Bio statistical analysis