A clinical trial to study effect of Homoeopathy and life style modification in stage I hypertension

Phase 3

Completed

• Conditions: Essential hypertension

• Registration Number: CTRI/2018/08/015228
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

The study will be a randomized double blind placebo controlled trial for a period of 3 months.

Group 1: Individualized homoeopathy+ life style modifications (IH+LSM).

Group 2: Control (life style modification- diet and exercise)

Purpose of the study is to evaluate the mean changes in Stage I hypertensive patients with respect to systolic and diastolic BP in clinical setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-02
• Study Completion: 2018-03-30
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• 30 to 60 yrs 2.Both genders 3.Essential hypertension of stage I (SBP 140-159; DBP 90-99) 4.Patients who were not on any anti-hypertensive medicine since last 1 month.
• 5.Patients willing to participate in the study.

Exclusion Criteria

• 1.Patients with secondary hypertension of any etiology.
• 2.Patients with pre hypertension, stage II hypertension as per JNC 7 criteria.
• 3.Known Diabetics.
• 4.Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect or known cases of cardiac diseases.
• 5.Patients with systemic illness 6.Patients receiving any drugs known to affect blood pressure 7.Patients judged to have a history of alcohol or drug abuse 8.Women who are taking contraceptive pills, pregnancy and lactating mother.
• 9.Patients suffering from hypothyroidism.
• 10.Unable or unwilling to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 To evaluate the mean change in systolic and diastolic blood pressure from baseline at every month for 3 months from baseline as per routine method.	every month for 3 months
2 To evaluate the changes in Ambulatory BP at 3rd month from baseline.	every month for 3 months

Secondary Outcome Measures

Name	Time	Method
Percent of patients meeting the goal BP of SBP≤ 135mmHg and DBP ≤85 mmHg in patients of both the groups	3 months

Trial Locations

Locations (7)

Clinical Research Unit (H) Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Clinical Research Unit (H) Tirupathi; 🇮🇳 Chittoor, ANDHRA PRADESH, India

Dr. Anjali Chatterjee Regional Research Institute Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Drug Standardization Extension Unit Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Homoeopathic Drug Research Institute(H) Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Regional Research Institute (H) Guwahati; 🇮🇳 Kamrup, ASSAM, India

Regional Research Institute (H) Imphal; 🇮🇳 East, MANIPUR, India

Clinical Research Unit (H) Chennai

🇮🇳Chennai, TAMIL NADU, India

Dr Papula Prasad

Principal investigator

09840771619

drpprasad2012@gmail.com