Clinical Evaluation of Tagara churna with Gokshuradi kwatha in Vyana bala vaishamya (Essential Hypertension Stage -1)

Phase 2

Not yet recruiting

• Conditions: Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH,

• Registration Number: CTRI/2022/08/045025
• Lead Sponsor: Uttarakhand Ayurveda University

Brief Summary

The trial will be conducted as a part of  Phd thesis.

A regime of Tagar churna 500mg bd and Gokshuradi kwatha 40ml bd will be given to one group while the other group will be prescribed Telmisartan 40mg od

Duration of the drug  trial will be 90 days

Each group will have 50 patients who will be selected randomly

The trial with the above said sample size will be completed within 2 years (24months)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed patients of essential hypertension stage 1 without any complication.
• Old cases of essential hypertension stage 1 without complications who have discontinued the antihypertensive medicine for at least 30 days 3.
• Age between 25 to 65 years.
• Blood pressure measurement in the OPD (7 consecutive days) Systolic blood pressure- 140-159 mmHg Diastolic blood pressure- 90-99 mmHg.

Exclusion Criteria

• Secondary hypertension 2.
• Blood pressure measurement in the OPD Systolic blood pressure- >159 mmHg Diastolic blood pressure- >99 mmHg 3.
• Any other coexisting serious medical & surgical illness.
• Patients with complication of Hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Shiroruja	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
2. Hriddrava	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
3. Klama	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
4. Bhrama	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
5. Akshiraga	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
6. Krodhaprachurya	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90
7. Alpanidra	Assessment will be done at an interval of 15 days starting from the registration i.e. | 1st Assessment at Day 15 | 2nd Assessment at Day 30 | 3rd Assessment at Day 45 | 4th Assessment at Day 60 | 5th Assessment at Day 75 | 6th Assessment at Day 90

Secondary Outcome Measures

Name	Time	Method
1. Systolic BP	2. Diastolic BP

Trial Locations

Locations (1)

Faculty of Ayurveda Hospital; 🇮🇳 Dehradun, UTTARANCHAL, India

Faculty of Ayurveda Hospital

🇮🇳Dehradun, UTTARANCHAL, India

Dr Jaya Saklani Kala

Principal investigator

9927249201

jk1ayush@gmail.com