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

Primary Purpose

Fatty Liver, Fatty Liver, Nonalcoholic

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Thyme
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thyme

Placebo

Arm Description

Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months

Wheat powder capsule 350 mg twice daily for 3 months

Outcomes

Primary Outcome Measures

Change in ALT (Alanin aminotransferase) level
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2016
Last Updated
October 3, 2017
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02983669
Brief Title
The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Fatty Liver, Nonalcoholic
Keywords
Thymus Plant, Multiflotriol [Supplementary Concept], Zataria multiflora, Complementary Therapies, Herbal Medicine, Medicine, traditional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thyme
Arm Type
Experimental
Arm Description
Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Wheat powder capsule 350 mg twice daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Thyme
Other Intervention Name(s)
Shirazi's Thyme
Intervention Description
Thyme capsule 350 mg twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule 350 mg twice daily
Primary Outcome Measure Information:
Title
Change in ALT (Alanin aminotransferase) level
Time Frame
3 months
Title
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in AST (Aspartate aminotransferase) level
Time Frame
3 months
Title
Fasting blood sugar (FBS)
Time Frame
3 months
Title
Change in Gama GT (γ-glutamyl transpeptidase) level
Time Frame
3 monyhs
Title
Fasting insulin level
Time Frame
3 months
Title
Body weight
Time Frame
3 months
Title
Waist circumference
Time Frame
3 months
Title
Hip circumference
Time Frame
3 months
Title
Number of patients with adverse events
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Nimruzi, MD
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mojtaba Heydari, MD
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasrin dokht Zamani, MD
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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