Nonalcoholic SteatohepatitisNASH NAFLDNCT02307344
Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis
A study testing Nigella Sativa in people with Nonalcoholic Steatohepatitis and Liver Steatosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Liver Steatosis
- What is being tested?
- Nigella Sativa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from Steatohepatitis
- Patients suffering from Liver Steatosis
Who cannot join
- Patients suffering from viral hepatitis
- Patients with HIV infection
- Patients suffering from Wilsons Disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Saif Abu Mouch, MD, 972-50-624-6966, saif@hy.health.gov.il
Saif Abu Mouch, MD
About this study
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
- Conditions
- Nonalcoholic Steatohepatitis, Liver Steatosis
- Being tested
- Nigella Sativa, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella SativaDietary supplement
PlaceboDietary supplement
Capsules that contain a placebo but look like the Nigella Sativa capsules
| Study group | Role | What they receive |
|---|---|---|
| Nigella Sativa Supplement | Active comparator | Fifty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest capsules containing 2 grams of Nigella Sativa divided into 1 grams twice a day. Receives: Dietary Supplement: Nigella Sativa |
| Patients receiving a placebo tablet | Active comparator | Twenty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest placebo capsules twice a day, that look like the capsules of those receiving the Nigella Sativa. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Nigella Sativa on Liver Triglyceride Concentration
The difference in change in the average liver triglyceride concentration will be measured by MRI Spectroscopy between the Nigella Sativa arm and the placebo arm, at start and end of the study.
Measured: One year
Secondary outcomes (2)
Effect of Nigella Sativa on Improvement in NASH Activity Index
Improvement in Nash activity Index will be measured by the NAFLD Activity Score.
Measured: One year
Effect of Nigella Sativa on Fibrosis Staging
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307344
- Sponsor's protocol ID
- 0002-14-HYMC
- Acronym
- NASH NAFLD
- Status last verified
- Dec 2014
- First submitted
- 3 Nov 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis
- ClinicalTrials.gov ID
- NCT02307344
- Acronym / sponsor ID
- NASH NAFLD / 0002-14-HYMC
- Conditions
- Nonalcoholic Steatohepatitis, Liver Steatosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 4 Dec 2014 (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 investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nigella Sativa Supplement | Active comparator | Dietary Supplement: Nigella SativaFifty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest capsules containing 2 grams of Nigella Sativa divided into 1 grams twice a day. |
| Patients receiving a placebo tablet | Active comparator | Dietary Supplement: PlaceboTwenty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest placebo capsules twice a day, that look like the capsules of those receiving the Nigella Sativa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from Steatohepatitis
- Patients suffering from Liver Steatosis
Key exclusion criteria (3 listed)
- Patients suffering from viral hepatitis
- Patients with HIV infection
- Patients suffering from Wilsons Disease
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 Sativa | Dietary supplement | Nigella Sativa Supplement |
| PlaceboCapsules that contain a placebo but look like the Nigella Sativa capsules | Dietary supplement | Patients receiving a placebo tablet |
Primary outcome
Effect of Nigella Sativa on Liver Triglyceride Concentration
Time frame: One year
The difference in change in the average liver triglyceride concentration will be measured by MRI Spectroscopy between the Nigella Sativa arm and the placebo arm, at start and end of the study.
2 secondary outcomes
Effect of Nigella Sativa on Improvement in NASH Activity Index
Time frame: One year
Effect of Nigella Sativa on Fibrosis Staging
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella Sativa in people with Nonalcoholic Steatohepatitis and Liver Steatosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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 4 Dec 2014. 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 Israel. 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.
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 Saif Abu Mouch, MD (972-506-246-966, saif@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Nigella Sativa on Liver Triglyceride Concentration (time frame: One year). 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 4 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.