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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Indonesia University.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Indonesia University

ClinicalTrials.gov Identifier:

NCT01393054

First received: July 12, 2011

Last updated: NA

Last verified: July 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 12, 2011

Last Updated Date

July 12, 2011

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

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

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 Blind (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

Estimated 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

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

Plan to Share Data

Not Provided

IPD Description

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

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