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

• DOI: 10.1186/s12906-025-04802-4
• Publication Date: 2025-03-01T11:13:34Z
• Authors: Babita Yadav; BCS Rao; Rajiv Narang; Sophia Jameela; Shruti Khanduri; Sakshi Sharma; Drishya Dinesh; Arti Srivastava; Richa Bhardwaj; Bharti Gupta; N Srikanth; Dharamvir Singh Arya
• Keywords: Amlodipine

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 management hypertension. The objective study to assess clinical efficacy safety Sarpgandha Management Stage-I Hypertension. This trial employs prospective design characterized by double-dummy, double-blind, placebo-controlled methodology being conducted at Cardiology Outpatient Department AIIMS, New Delhi. A total 150 participants (75 per group), diagnosed essential hypertension will be randomized allocated 1:1 allocation ratio, either group or Conventional Care group. Participants Group I receive Ayurvedic intervention, 500 mg capsules orally twice daily, addition matching placebo Amlodipine 5 once daily. II along All also administered Hydrochlorothiazide 12.5 tablets daily duration 12 weeks. primary endpoint this involves evaluating changes SBP DBP from baseline week 12. Secondary outcome includes assessing IL-6, Serum Pro-BNP, oxidative stress markers, lipid profile, SF-36 Health Survey Score. Safety assessments done through recording AE/ADR liver function tests renal parameters. present poised furnish comprehensive insights into profile Grade 1 By adopting rigorous scientific methodology, investigation aims contribute robust evidence that may significantly impact formulation future guidelines integrative treatment protocols management. prospectively registered Clinical Trial Registry India [CTRI/2021/12/038589], dated 13.12.2021.