The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Conditions
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Fatty Liver, Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Dietary Supplement: Thyme
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnancy and Lactation Acute or chronic liver failure Acute or chronic renal failure Autoimmune or viral hepatitis Wilson's disease Diabetes mellitus 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thyme<br>Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months | Dietary Supplement: Thyme<br>* Thyme capsule 350 mg twice daily<br>* Other names: Shirazi's Thyme;|
| Placebo Comparator: Placebo<br>Wheat powder capsule 350 mg twice daily for 3 months | Other: Placebo<br>* Placebo capsule 350 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ALT (Alanin aminotransferase) level |  | 3 months | 
| Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AST (Aspartate aminotransferase) level |  | 3 months | 
| Fasting blood sugar (FBS) |  | 3 months | 
| Change in Gama GT (γ-glutamyl transpeptidase) level |  | 3 monyhs | 
| Fasting insulin level |  | 3 months | 
| Body weight |  | 3 months | 
| Waist circumference |  | 3 months | 
| Hip circumference |  | 3 months | 
| Number of patients with adverse events |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional