DyslipidemiaPhase 2NCT01531062
Effect of Nigella Sativa on Lipid Profiles in Elderly
A Phase 2 study testing Nigella sative and black sticky rice in people with Dyslipidemia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Nigella sative and black sticky rice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIndonesia
- Study dates
- Sep 2011to Dec 2011
- Phase
- Phase 2
- 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
- age of 60 years or more
- having dyslipidemia (total cholesterol >200 mg/dL or LDL >100 mg/dL or triglyceride > 150 mg/dL or HDL < 40 mg/dL (male) or HDL < 50 mg/dL (female)
Who cannot join
- ALT or AST are two times of upper normal limit
- creatinine clearance test is below 30
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Internal Medicine Department, Faculty of Medicine, University Indonesia
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial
The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.
Read the detailed description
Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.
- Conditions
- Dyslipidemia
- Being tested
- Nigella sative, black sticky rice
- Keywords
- nigella sativa, dyslipidemia, elderly
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativeDrug
Nigella sativa seed extracts, 300 mg capsule bid, for 56 days
black sticky riceDietary supplement
300 mg capsule bid, 56 days
| Study group | Role | What they receive |
|---|---|---|
| Nigella sativa | Experimental | Nigella sativa extracts, 300 mg twice daily Receives: Drug: Nigella sative |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: black sticky rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Tandradynata, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531062
- Sponsor's protocol ID
- Nigella sativa
- Status last verified
- Feb 2012
- First submitted
- 8 Feb 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT01531062
- Acronym / sponsor ID
- Nigella sativa
- Conditions
- Dyslipidemia
- Keywords
- nigella sativa, dyslipidemia, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Feb 2012 (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.
The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.
Detailed description
Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nigella sativa | Experimental | Drug: Nigella sativeNigella sativa extracts, 300 mg twice daily |
| Placebo | Placebo comparator | Dietary Supplement: black sticky rice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age of 60 years or more
- having dyslipidemia (total cholesterol >200 mg/dL or LDL >100 mg/dL or triglyceride > 150 mg/dL or HDL < 40 mg/dL (male) or HDL < 50 mg/dL (female)
Key exclusion criteria (2 listed)
- ALT or AST are two times of upper normal limit
- creatinine clearance test is below 30
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 sativeNigella sativa seed extracts, 300 mg capsule bid, for 56 days | Drug | Nigella sativa |
| black sticky rice300 mg capsule bid, 56 days | Dietary supplement | Placebo |
Primary outcome
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nigella sative and black sticky rice in people with Dyslipidemia, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Feb 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL (time frame: 56 days). 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 10 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.