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

The recruitment status of this study is unknown because the information has not been verified recently.
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

July 12, 2011
July 12, 2011
July 2011
October 2011   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
Drug: Nigella sativa
Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Aulia Rizka, MD +628125265600 dr.auliarizka@yahoo.co.id
Contact: Siti Setiati, PhD, MD +6281389835588 s_setiati@yahoo.com
Indonesia
 
NCT01393054
NS2602
Yes
Aulia Rizka, MD, Faculty of Medicine University of Indonesia
Indonesia University
Not Provided
Principal Investigator: Aulia Rizka, MD Faculty of Medicine University of Indonesia
Indonesia University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP