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

This study is currently recruiting participants.
Verified July 2011 by Indonesia University
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • systolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: Nigella sativa
    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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Indonesia: National Agency of Drug and Food Control

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 June 17, 2013