Fatty LiverThymeLivNCT02983669
The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease
A study testing Thyme in people with Fatty Liver and Fatty Liver, Nonalcoholic, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatty Liver, Fatty Liver, Nonalcoholic
- What is being tested?
- Thyme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteIran
- Study dates
- Jan 2017to 10 May 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-65 years
- Body mass index: 18-35 kg/m2
- Serum ALT level: >45 U/Lit. in Males, >29 U/Lit. in Females
- Grade >=1 fatty liver in liver sonography
Who cannot join
- Pregnancy and Lactation
- Acute or chronic liver failure
- Acute or chronic renal failure
- Autoimmune or viral hepatitis
- Wilson's disease
- Diabetes mellitus
Show all 11Show fewer
- Alcoholism
- Malignancy
- Hypothyroidism or hyperthyroidism
- Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid, glucocorticoids, thiazolidenediones.
- History of allergic reactions to Thyme
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
About this study
Official title: The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD).
Read the detailed description
In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.
- Conditions
- Fatty Liver, Fatty Liver, Nonalcoholic
- Being tested
- Thyme, Placebo
- Keywords
- Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymeDietary supplement
Also called Shirazi's Thyme
Thyme capsule 350 mg twice daily
PlaceboOther
Placebo capsule 350 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Thyme | Experimental | Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months Receives: Dietary Supplement: Thyme |
| Placebo | Placebo comparator | Wheat powder capsule 350 mg twice daily for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALT (Alanin aminotransferase) level
Measured: 3 months
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
Measured: 3 months
Secondary outcomes (8)
Change in AST (Aspartate aminotransferase) level
Measured: 3 months
Fasting blood sugar (FBS)
Measured: 3 months
Change in Gama GT (γ-glutamyl transpeptidase) level
Measured: 3 monyhs
Fasting insulin level
Measured: 3 months
Body weight
Measured: 3 months
Waist circumference
Measured: 3 months
Hip circumference
Measured: 3 months
Number of patients with adverse events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion20 Apr 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Majid Nimruzi, MD, Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, IranMojtaba Heydari, MD, Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, IranNasrin dokht Zamani, MD, Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983669
- Sponsor's protocol ID
- 94-7648
- Acronym
- ThymeLiv
- Status last verified
- Oct 2017
- First submitted
- 2 Dec 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02983669
- Acronym / sponsor ID
- ThymeLiv / 94-7648
- Conditions
- Fatty Liver, Fatty Liver, Nonalcoholic
- Keywords
- Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 6 Dec 2016 (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 aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD).
Detailed description
In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.
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 |
|---|---|---|
| Thyme | Experimental | Dietary Supplement: ThymeZataria multiflora Boiss powder capsule 350 mg twice daily for 3 months |
| Placebo | Placebo comparator | Other: PlaceboWheat powder capsule 350 mg twice daily for 3 months |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 20-65 years
- Body mass index: 18-35 kg/m2
- Serum ALT level: >45 U/Lit. in Males, >29 U/Lit. in Females
- Grade >=1 fatty liver in liver sonography
Key exclusion criteria (11 listed)
- Pregnancy and Lactation
- Acute or chronic liver failure
- Acute or chronic renal failure
- Autoimmune or viral hepatitis
- Wilson's 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 |
|---|---|---|
| ThymeAlso: Shirazi's ThymeThyme capsule 350 mg twice daily | Dietary supplement | Thyme |
| PlaceboPlacebo capsule 350 mg twice daily | Other | Placebo |
Primary outcome
Change in ALT (Alanin aminotransferase) level
Time frame: 3 months
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
Time frame: 3 months
8 secondary outcomes
Change in AST (Aspartate aminotransferase) level
Time frame: 3 months
Fasting blood sugar (FBS)
Time frame: 3 months
Change in Gama GT (γ-glutamyl transpeptidase) level
Time frame: 3 monyhs
Fasting insulin level
Time frame: 3 months
Body weight
Time frame: 3 months
Waist circumference
Time frame: 3 months
Hip circumference
Time frame: 3 months
Number of patients with adverse events
Time frame: 4 months
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 4 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Majid Nimruzi, MD principal investigator
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Mojtaba Heydari, MD principal investigator
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Nasrin dokht Zamani, MD principal investigator
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyme in people with Fatty Liver and Fatty Liver, Nonalcoholic, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 11 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 4 Oct 2017. 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 Iran. 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.
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?
Change in ALT (Alanin aminotransferase) level (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Oct 2017.