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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nigella sativa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic blood pressure | We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nigella sativa seed extract, hypertension, elderly