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

Tracking Information
First Submitted Date ICMJE	July 12, 2011
First Posted Date ICMJE	July 13, 2011
Last Update Posted Date	July 13, 2011
Study Start Date ICMJE	July 2011
Estimated Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 12, 2011)	systolic blood pressure [ Time Frame: 4 weeks ]; 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
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: July 12, 2011)	diastolic blood pressure [ Time Frame: 4 weeks ]; We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Official Title ICMJE	Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Brief 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.
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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	Drug: Nigella sativa; Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: July 12, 2011)	76
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2011
Estimated Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	60 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Indonesia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01393054
Other Study ID Numbers ICMJE	NS2602
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Aulia Rizka, MD, Faculty of Medicine University of Indonesia
Study Sponsor ICMJE	Indonesia University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Aulia Rizka, MD Faculty of Medicine University of Indonesia
PRS Account	Indonesia University
Verification Date	July 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP