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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: Nigella sativa

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Recruiting
    • Cipto Mangunkusumo National Hospital
    • Contact: Aulia Rizka, MD; Phone Number: +628125265600; Email: dr.auliarizka@yahoo.co.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure	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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic blood pressure	We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension	4 weeks

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Aulia Rizka, MD, Faculty of Medicine University of Indonesia

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): July 13, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: elderly; hypertension; Nigella sativa seed extract
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NS2602