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

Fatty Liver Clinical Trial

— ThymeLiv  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983669
• Other study ID #: 94-7648
• Status: Completed
• Phase: N/A
• First received: December 2, 2016
• Last updated: October 3, 2017
• Start date: January 2017
• Est. completion date: May 10, 2017

Study information

• Verified date: October 2017
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 10, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Thyme
Thyme capsule 350 mg twice daily

Other:
• Placebo
Placebo capsule 350 mg twice daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ALT (Alanin aminotransferase) level		3 months
Primary	Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System		3 months
Secondary	Change in AST (Aspartate aminotransferase) level		3 months
Secondary	Fasting blood sugar (FBS)		3 months
Secondary	Change in Gama GT (?-glutamyl transpeptidase) level		3 monyhs
Secondary	Fasting insulin level		3 months
Secondary	Body weight		3 months
Secondary	Waist circumference		3 months
Secondary	Hip circumference		3 months
Secondary	Number of patients with adverse events		4 months