Overview

This trial is active, not recruiting.

Condition fatty liver
Treatments ginger, placebo
Phase phase 0
Sponsor Shiraz University of Medical Sciences
Start date November 2014
End date November 2016
Trial size 90 participants
Trial identifier NCT02289235, CT-P-9364-6254

Summary

The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ginger powder capsule 500 mg daily for 3 months
ginger
Ginger powder capsule 500 mg daily for 3 months
(Placebo Comparator)
Placebo powder 1 capsule daily for 3 months
placebo
Placebo powder 1 capsule daily for 3 months

Primary Outcomes

Measure
Change in ALT (liver transaminases) level
time frame: Baseline and 3 months
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
time frame: Baseline and 3 months

Secondary Outcomes

Measure
Change in AST (liver transaminases) level
time frame: Baseline and 3 months
Change in Gama GT (γ-glutamyl transpeptidase) levels
time frame: Baseline and 3 months
Number of patients with adverse events
time frame: 4 months

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - 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 - Diabetes mellitus - Alcoholism - Malignancy - Hypothyroidism or hyperthyroidism - Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid, glucocorticoids, thiazolidenediones.

Additional Information

Official title The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Principal investigator Majid Nimruzi, M.D.
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Shiraz University of Medical Sciences.