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

• ClinicalTrials.gov Identifier: NCT01393054
• Recruitment Status: Unknown
• First Posted: July 13, 2011
• Last Update Posted: July 13, 2011
• Sponsor: Indonesia University
• Information provided by: Indonesia University

Tracking Information

• First Submitted Date: July 12, 2011
• First Posted Date: July 13, 2011
• Last Update Posted Date: July 13, 2011
• Study Start Date: July 2011
• Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 12, 2011): 76
• Original Estimated Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT01393054
• Other Study ID Numbers: NS2602
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Aulia Rizka, MD, Faculty of Medicine University of Indonesia
• Original Responsible Party: Same as current
• Current Study Sponsor: Indonesia University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aulia Rizka, MD; Faculty of Medicine University of Indonesia

• PRS Account: Indonesia University
• Verification Date: July 2011