HypertensionPhase 3NCT01393054
Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
A Phase 3 study testing Nigella sativa in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nigella sativa
- Type of treatment
- Pill or oral medicine
- How many people
- 76 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Renal failure
- Hepatic failure
- Dementia
- Orthostatic hypotension
- Malignant hypertension
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Special Capital Region
Aulia Rizka, MD, +628125265600, dr.auliarizka@yahoo.co.id
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Nigella sativa
- Keywords
- Nigella sativa seed extract, hypertension, elderly
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativaDrug
Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Investigators
- Aulia Rizka, MD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393054
- Sponsor's protocol ID
- NS2602
- Status last verified
- Jul 2011
- First submitted
- 12 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
- ClinicalTrials.gov ID
- NCT01393054
- Acronym / sponsor ID
- NS2602
- Conditions
- Hypertension
- Keywords
- Nigella sativa seed extract, hypertension, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- Renal failure
- Hepatic failure
- Dementia
- Orthostatic hypotension
- Malignant hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella sativaDrug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks | Drug | – |
Primary outcome
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
1 secondary outcome
diastolic blood pressure
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aulia Rizka, MD principal investigator
Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nigella sativa in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aulia Rizka, MD (+628125265600, dr.auliarizka@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.