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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393054
• Other study ID #: NS2602
• Status: Recruiting
• Phase: Phase 3
• First received: July 12, 2011
• Last updated: July 12, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Indonesia University
• Contact: Aulia Rizka, MD
• Phone: +628125265600
• Email: dr.auliarizka[@]yahoo.co.id
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nigella sativa
Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No