Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension

Phase 3

• Conditions: Hypertension

• Registration Number: NCT01393054
• Lead Sponsor: Indonesia University

Brief Summary

Despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. Nigella sativa seed extract, derived from a small plant originating in Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. We will conduct a randomized, double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.

Detailed Description

The study will be conducted in Geriatric Outpatient Clinic of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia.

Eligibility criteria are men and women over 60 years old and available to participate in the study for 4 weeks with blood pressure higher than 140/90.

Exclusion criteria are renal disease, hepatic failure, dementia and orthostatic hypotension and malignant hypertension.

Outcome measures are systolic and diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract twice daily.

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Men and women more than 60 years old
• Systolic Blood Pressure 140 mm Hg AND OR diastolic blood pressure 90 mmHg
• Available during study duration (4 weeks)

Exclusion Criteria

• Renal failure
• Hepatic failure
• Dementia
• Orthostatic hypotension
• Malignant hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
systolic blood pressure	4 weeks	We aim to measure the difference in systolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension

Secondary Outcome Measures

Name	Time	Method
diastolic blood pressure	4 weeks	We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia