Anti-hypertensive and pleiotropic effects of Moringa oleifera leaf extract as an add-on therapy in patients with essential hypertension - A randomized double blind placebo controlled trial.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- JIPMER Puducherry
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in systolic blood pressure at the end of 3 months
Study Overview
Brief Summary
This study is a randomized double blind placebo controlled trial to evaluate the effect of Moringa oleifera leaf extract as an add on treatment in patients with essential hypertension. The study will have two arms- the intervention arm and the placebo arm. The study will be conducted with 150 participants, 75 in each group, all of whom will be recruited from JIPMER, Puducherry. The participants will receive either the intervention or placebo capsules at a dose of 600 mg thrice daily for a period of three months. At the end of three months, the participants will be assessed for mean reduction in systolic blood pressure, mean reduction in diastolic blood pressure, oxidative stress marker and antioxidant level, HbA1c level, liver and renal function test, lipid profile, hs-CRP, serum uric acid level and endothelial function using plethysmography and will be compared to baseline.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with essential hypertension aged ≥ 18 years, irrespective of gender, with or without other comorbidities, who fulfill the following criteria: Patients on treatment with stable dose of antihypertensive agents for atleast 1 month and has not yet attained target blood pressure goals (130 mm Hg of systolic and 80 mm Hg of diastolic blood pressure) and not requiring dose escalation or addition of new anti-hypertensive agent according to clinical judgment of the treating physician.
Exclusion Criteria
- •Patients with secondary hypertension.
- •Patients with hypertensive urgency or emergency.
- •Patients not on stable dose of oral hypoglycemic drugs or insulin for past 1 month.
- •Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures.
- •Patients with hepatic impairment (elevated liver enzymes more than 2 times upper normal limit) Patients with renal impairment (serum Creatinine more than 1.2 mg per dl) Patients with recent history of coronary artery disease Patients with peripheral vascular disease.
- •Patients who had participated in other trials in the past three months.
Outcomes
Primary Outcomes
Mean change from baseline in systolic blood pressure at the end of 3 months
Time Frame: 3 months
Secondary Outcomes
- Mean change from baseline in diastolic blood pressure, HbA1c level, oxidative stress marker and antioxidant level, hs-CRP, liver and renal function, lipid profile, serum uric acid level and endothelial function using plethysmography at the end of 3 months(3 months)
- Safety of Moringa oleifera leaf extract in essential hypertension patients(3 months)
Investigators
Dr Harivenkatesh Natarajan
Jawaharlal Institute of Postgraduate Medical Education & Research