Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Jul 2011
Shorter than P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 13, 2011
July 1, 2011
3 months
July 12, 2011
July 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
systolic blood pressure
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
4 weeks
Secondary Outcomes (1)
diastolic blood pressure
4 weeks
Interventions
Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Renal failure
- Hepatic failure
- Dementia
- Orthostatic hypotension
- Malignant hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aulia Rizka, MD
Faculty of Medicine University of Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 13, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
July 13, 2011
Record last verified: 2011-07