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

NCT ID: NCT02983669

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-05-10

Brief Summary

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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

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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.

Conditions

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Fatty Liver Fatty Liver, Nonalcoholic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Thyme

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

Group Type EXPERIMENTAL

Thyme

Intervention Type DIETARY_SUPPLEMENT

Thyme capsule 350 mg twice daily

Placebo

Wheat powder capsule 350 mg twice daily for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule 350 mg twice daily

Interventions

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Thyme

Thyme capsule 350 mg twice daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule 350 mg twice daily

Intervention Type OTHER

Other Intervention Names

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Shirazi's Thyme

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mesbah Shams, MD

Associate professor of Internal medicine and Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Majid Nimruzi, MD

Role: PRINCIPAL_INVESTIGATOR

Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Mojtaba Heydari, MD

Role: PRINCIPAL_INVESTIGATOR

Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Nasrin dokht Zamani, MD

Role: PRINCIPAL_INVESTIGATOR

Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Locations

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Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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94-7648

Identifier Type: -

Identifier Source: org_study_id