A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VAASATHI KASHAYAM IN THE MANAGEMENT OF RATHTHA KOTHIPPU NOI (SYSTEMIC HYPERTENSION)

This is a PROSPECTIVE  OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VAASATHI KASHAYAM IN THE MANAGEMENT OF RATHTHA KOTHIPPU NOI (SYSTEMIC HYPERTENSION). The trial drug ’Vaasathi kashayam’ is freshly prepared and will be administered at a dosage of30-60 ml (Twice a day orally) with Jaggery (Naatu charkarai) as adjuvant for 50 days for 50 known primary hypertensive patients (30 OP & 20 IP patients) with Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg). The primary outcome will be determining the clinical efficacy of VAASATHI KASHAYAM (INTERNAL) in the management of RATHTHA KOTHIPPU NOI (SYSTEMIC HYPERTENSION). The secondary outcome will be to collect various Siddha literatures and modern journals for literature review on RATHTHA KOTHIPPU NOI, 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 VAASATHI KASHAYAM, to evaluate safety profile for acute and sub-acute toxicity of -VAASATHI KASHAYAM, to evaluate pharmacological activities of VAASATHI KASHAYAM, to perform in-vitro, in-vivo studies, to perform molecular docking studies on the trial drug in ACE inhibitor and Angiotensin receptor blocker activities, to perform cell line studies for its anti-hypertensive activities, to study about the prevalence of RATHTHA KOTHIPPU NOI in relation with diet and lifestyle, to evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in RATHTHA KOTHIPPU NOI during trial period and to evaluate modern parametric changes in RATHTHA KOTHIPPU NOI.