This study is currently recruiting participants.
Verified on July 2011 by Indonesia University
First Received on July 12, 2011. No Changes Posted
Sponsor: Indonesia University
Information provided by: Indonesia University
ClinicalTrials.gov Identifier: NCT01393054
Purpose
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.
Condition Intervention Phase
Hypertension
Drug: Nigella sativa
Phase III
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
MedlinePlus related topics: High Blood Pressure
U.S. FDA Resources
Primary Outcome Measures:
systolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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:
diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension
Estimated Enrollment: 76
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:Drug: Nigella sativa
Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
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.
Eligibility
Ages Eligible for Study: 60 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393054
Contacts
Contact: Aulia Rizka, MD +628125265600 dr.auliarizka@yahoo.co.id
Contact: Siti Setiati, PhD, MD +6281389835588 s_setiati@yahoo.com
Locations
Indonesia
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia
Contact: Aulia Rizka, MD +628125265600 dr.auliarizka@yahoo.co.id
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Aulia Rizka, MD Faculty of Medicine University of Indonesia
Where to buy Black seed oil
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