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

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).

Study Overview

• Status: Completed
• Conditions: Fatty Liver; Fatty Liver, Nonalcoholic
• Intervention / Treatment: Dietary supplement: Thyme; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thyme; Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months	Dietary supplement: Thyme; Thyme capsule 350 mg twice daily; Other Names: Shirazi's Thyme
Placebo Comparator: Placebo; Wheat powder capsule 350 mg twice daily for 3 months	Other: Placebo; Placebo capsule 350 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Body weight	3 months
Waist circumference	3 months
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
Hip circumference	3 months
Number of patients with adverse events	4 months

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Mojtaba Heydari, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Principal Investigator: Majid Nimruzi, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Principal Investigator: Nasrin dokht Zamani, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Complementary Therapies; Herbal Medicine; Medicine, traditional; Thymus Plant; Multiflotriol [Supplementary Concept]; Zataria multiflora
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 94-7648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided