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

Not Applicable

Completed

• Conditions: Fatty Liver, Nonalcoholic; Fatty Liver
• Interventions: Dietary Supplement: Thyme; Other: Placebo

• Registration Number: NCT02983669
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-06
• Study Start: 2017-01
• Primary Completion: 2017-04-20
• Study Completion: 2017-05-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thyme	Thyme	Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months
Placebo	Placebo	Wheat powder capsule 350 mg twice daily for 3 months

Primary Outcome Measures

Name	Time	Method
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System	3 months
Change in ALT (Alanin aminotransferase) level	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of