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

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Nigella sativa	Phase 3


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

Further study details as provided by Indonesia University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	76
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)

Intervention Details:

Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks

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.

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393054

Contacts


Contact: Aulia Rizka, MD	+628125265600	dr.auliarizka@yahoo.co.id
Contact: Siti Setiati, PhD, MD	+6281389835588	s_setiati@yahoo.com

Locations


Indonesia
Cipto Mangunkusumo National Hospital	Recruiting
Jakarta, Indonesia
Contact: Aulia Rizka, MD +628125265600 dr.auliarizka@yahoo.co.id

Sponsors and Collaborators

Indonesia University

Investigators


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

More Information


Responsible Party:	Aulia Rizka, MD, Faculty of Medicine University of Indonesia
ClinicalTrials.gov Identifier:	NCT01393054 History of Changes
Other Study ID Numbers:	NS2602
Study First Received:	July 12, 2011
Last Updated:	July 12, 2011

Keywords provided by Indonesia University:


Nigella sativa seed extract hypertension elderly

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 22, 2017

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