Fatty Liver, Fatty Liver, Nonalcoholic
Conditions
Keywords
Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional
Brief 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).
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.
Interventions
OTHERPlacebo
Placebo capsule 350 mg twice daily
DIETARY_SUPPLEMENTThyme
Thyme capsule 350 mg twice daily
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Fasting blood sugar (FBS) | 3 months |
| Fasting insulin level | 3 months |
| Body weight | 3 months |
| Change in Gama GT (γ-glutamyl transpeptidase) level | 3 monyhs |
| Hip circumference | 3 months |
| Number of patients with adverse events | 4 months |
| Waist circumference | 3 months |
| Change in AST (Aspartate aminotransferase) level | 3 months |
Countries
Iran
Outcome results
None listed