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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
Sponsor:
Information provided by:
Indonesia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nigella sativa Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
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
Study Start Date : July 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Nigella sativa
    Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393054


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

Locations
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Indonesia
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia
Contact: Aulia Rizka, MD    +628125265600    dr.auliarizka@yahoo.co.id   
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Aulia Rizka, MD Faculty of Medicine University of Indonesia
More Information
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Responsible Party: Aulia Rizka, MD, Faculty of Medicine University of Indonesia
ClinicalTrials.gov Identifier: NCT01393054    
Other Study ID Numbers: NS2602
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011
Keywords provided by Indonesia University:
Nigella sativa seed extract
hypertension
elderly
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases