Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Recruitment status was Recruiting
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 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|
- 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
- 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
|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)|
Drug: Nigella sativa
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393054
|Contact: Aulia Rizka, MDfirstname.lastname@example.org|
|Contact: Siti Setiati, PhD, MDemail@example.com|
|Cipto Mangunkusumo National Hospital||Recruiting|
|Contact: Aulia Rizka, MD +628125265600 firstname.lastname@example.org|
|Principal Investigator:||Aulia Rizka, MD||Faculty of Medicine University of Indonesia|