Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

NCT ID: NCT02289235

Last Updated: 2020-10-20

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

EARLY_PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-01

Brief Summary

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The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Detailed Description

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Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.

In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Conditions

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Fatty Liver Diabetes Mellitus, Type 2

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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Ginger

Ginger powder capsule 500 mg

Group Type EXPERIMENTAL

Ginger

Intervention Type DRUG

Ginger powder capsule 1000 mg twice daily for 3 months

Placebo

Placebo powder capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo powder 2 capsules twice daily for 3 months

Interventions

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Ginger

Ginger powder capsule 1000 mg twice daily for 3 months

Intervention Type DRUG

Placebo

Placebo powder 2 capsules twice daily for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Controlled type 2 diabetes mellitus (HbA1c\<7%)
* Age: 20-65 years
* Body mass index: 18-35 kg/m2
* Serum ALT level: \>60 U/Lit. in males, \>38 U/Lit. in females
* Grade \>=2 fatty liver in liver sonography

Exclusion Criteria

* Pregnancy
* Acute or chronic liver failure
* Acute or chronic renal failure
* Autoimmune or viral hepatitis
* Wilson's disease
* Alcoholism
* Malignancy
* Hypothyroidism or hyperthyroidism
* Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.
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 & Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mesbah Shams, M.D.

Role: STUDY_CHAIR

Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Majid Nimruzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research Center for Traditional Medicine, Shiraz University of Medical Sciences

Kamran Bagheri Lankarani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Health policy Research Center, Shiraz University of Medical Sciences

Parisa-sadaat Ghoreishi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

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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CT-P-9364-6254

Identifier Type: -

Identifier Source: org_study_id

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