A clinical trial to study the BP reduction and other protective effects of amla extract (phyllanthus emblica) as an add-on to standard treatment in patients with hypertension of unknown cause

Not Applicable

Completed

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2018/05/013669
• Lead Sponsor: JIPMER Puducherry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients with essential hypertension aged >= 18 years, irrespective of gender, who meet any one of the following criteria

1.Newly diagnosed and started on amlodipine 5 mg or enalapril 5 mg

2.Already on treatment with stable dose of amlodipine 5 mg or enalapril 5 mg for atleast 1 month and has not yet attained target blood pressure goals (130 mmHg of systolic and 80 mmHg of diastolic blood pressure) and not requiring dose escalation or addition of second anti-hypertensive agent according to clinical judgment of the treating physician

Exclusion Criteria

1. Patients with secondary hypertension

2. Patients with systolic BP >160 mmHg and diastolic BP >100 mmHg

3. Patients with hypertensive urgency/ emergency

4. Patients receiving antihypertensive drugs other than amlodipine and enalapril

5. Patients not on stable dose of oral hypoglycemic drugs and/or insulin for past 1 month

6. Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures

7. Patients with hepatic impairment (elevated liver enzymes > 2 times upper normal limit)

8. Patients with renal impairment (S.Creatinine > 1.2 mg/dL)

9. Patients with history of coronary artery disease and peripheral vascular disease

10. Patients who had participated in other trials in the past three months.

11. Patients on herbal medications

12. Patients not willing to sign written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean reduction in systolic blood pressure from baseline at end of 3 monthsTimepoint: Mean reduction in systolic blood pressure from baseline at end of 3 months

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in diastolic blood pressure, serum uric acid, HbA1c, liver function, lipid levels, hs-CRP, oxidant and anti-oxidant levels, pulse wave velocity at end of 3 monthsTimepoint: Mean change from baseline in diastolic blood pressure, serum uric acid, HbA1c, liver function, lipid levels, hs-CRP, oxidant and anti-oxidant levels, pulse wave velocity at end of 3 months