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

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

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

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
Contact: Aulia Rizka, MD | +628125265600 | dr.auliarizka@yahoo.co.id | |
Contact: Siti Setiati, PhD, MD | +6281389835588 | s_setiati@yahoo.com |
Indonesia | |
Cipto Mangunkusumo National Hospital | Recruiting |
Jakarta, Indonesia | |
Contact: Aulia Rizka, MD +628125265600 dr.auliarizka@yahoo.co.id |
Principal Investigator: | Aulia Rizka, MD | Faculty of Medicine University of Indonesia |
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 |
Nigella sativa seed extract hypertension elderly |
Hypertension Vascular Diseases Cardiovascular Diseases |