Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
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ClinicalTrials.gov Identifier: NCT01393054 |
Recruitment Status : Unknown
Verified July 2011 by Indonesia University.
Recruitment status was: Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
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Sponsor:
Indonesia University
Information provided by:
Indonesia University
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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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
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Study Arms ICMJE | 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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
76 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2011 | |||
Estimated Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | |||
Current Responsible Party | Aulia Rizka, MD, Faculty of Medicine University of Indonesia | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Indonesia University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |