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

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Hypertension

Treatments: Drug: Nigella sativa

Study type: Interventional

Funder types: Other

Identifiers

NCT01393054

NS2602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind