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

Background

High blood pressure, or hypertension, is a major health risk for heart diseases. Most people with hypertension live in low- and middle-income countries. This study focuses on a traditional Ayurvedic treatment called Sarpagandha Mishran to see how well it works for managing Stage-I hypertension.

Study Method

This clinical trial is designed to be very scientific. It involves 150 participants diagnosed with Stage-I hypertension, split into two groups:

  • Group I: Receives Sarpagandha Mishran capsules twice a day and a placebo for Amlodipine.
  • Group II: Receives Amlodipine capsules once a day and a placebo for Sarpagandha Mishran.

Everyone will also take Hydrochlorothiazide once daily for 12 weeks. The main goal is to measure blood pressure changes after 12 weeks. Other health markers will also be checked.

Expected Results

The study aims to provide clear evidence about how effective and safe Sarpagandha Mishran is for treating Stage-I hypertension. This could help shape future treatment guidelines.

Future Steps

We will analyze data to identify any opportunities based on the results. Measurable outcomes will be defined to help clinics and patients understand the effectiveness and safety of the treatment.

Using AI Tools

We will select AI tools that match clinical needs to enhance our study and its impact.

Implementation

A pilot project will be initiated, and results will be tracked to understand the real-world effectiveness of the treatment.

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