Efficacy and safety of ayurvedic intervention (Sarpgandha Mishran) vs amlodipine for Stage-I primary hypertension- study protocol for a prospective Double-Dummy, Double-Blind, placebo-controlled Randomized Clinical Trial.

Abstract

Background: Hypertension presents as a modifiable risk factor for cardiovascular diseases, with approximately two-thirds of the global hypertensive population concentrated in low- and middle-income nations. Sarpagandha Mishran is an Ayurveda intervention utilized for the management of hypertension. The objective of the study is to assess the clinical efficacy and safety of Sarpgandha Mishran in the Management of Stage-I Hypertension.

Methods: This clinical trial employs a prospective design characterized by a double-dummy, double-blind, placebo-controlled methodology being conducted at Cardiology Outpatient Department of the AIIMS, New Delhi. A total of 150 participants (75 per group), diagnosed with Stage-I essential hypertension will be randomized and allocated in a 1:1 allocation ratio, to either Ayurveda group or Conventional Care group. Participants in Group I will receive Ayurvedic intervention, Sarpagandha Mishran 500 mg capsules orally twice daily, in addition to a matching placebo of Amlodipine 5 mg capsules orally once daily. Group II will receive a matching placebo of Sarpagandha Mishran 500 mg capsules along with Amlodipine 5 mg capsules orally once daily. All participants will also be administered Hydrochlorothiazide 12.5 mg tablets orally once daily for a duration of 12 weeks. The primary endpoint of this study involves evaluating changes in SBP and DBP from baseline to week 12. Secondary outcome includes assessing changes in IL-6, Serum Pro-BNP, oxidative stress markers, lipid profile, and the SF-36 Health Survey Score. Safety assessments will be done through recording of AE/ADR and assessments of liver function tests and renal function tests parameters.

Discussion: The present study is poised to furnish comprehensive insights into the clinical efficacy and safety profile of Sarpagandha Mishran in the management of Grade 1 hypertension. By adopting a rigorous scientific methodology, this investigation aims to contribute robust evidence that may significantly impact the formulation of future guidelines for integrative treatment protocols in hypertension management.

Trial registration: The trial is prospectively registered with the Clinical Trial Registry of India [CTRI/2021/12/038589], dated 13.12.2021.