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

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Nigella sativa

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Nigella sativa seed extract, hypertension, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cipto Mangunkusumo National HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01393054

First Posted

July 12, 2011

Last Updated

July 12, 2011

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT01393054

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Indonesia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Nigella sativa seed extract, hypertension, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nigella sativa

Intervention Description

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

Primary Outcome Measure Information:

Title

systolic blood pressure

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

diastolic blood pressure

Description

We measure the difference of diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aulia Rizka, MD

Phone

+628125265600

dr.auliarizka@yahoo.co.id

First Name & Middle Initial & Last Name or Official Title & Degree

Siti Setiati, PhD, MD

Phone

+6281389835588

s_setiati@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aulia Rizka, MD

Organizational Affiliation

Faculty of Medicine University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cipto Mangunkusumo National Hospital

City

Jakarta

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aulia Rizka, MD

Phone

+628125265600

dr.auliarizka@yahoo.co.id

12. IPD Sharing Statement

Learn more about this trial

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

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