Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
NCT ID: NCT02289235
Last Updated: 2020-10-20
Study Results
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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COMPLETED
EARLY_PHASE1
76 participants
INTERVENTIONAL
2019-05-01
2020-02-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ginger
Ginger powder capsule 500 mg
Ginger
Ginger powder capsule 1000 mg twice daily for 3 months
Placebo
Placebo powder capsule
Placebo
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
Placebo
Placebo powder 2 capsules twice daily for 3 months
Eligibility Criteria
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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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
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
Countries
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Other Identifiers
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CT-P-9364-6254
Identifier Type: -
Identifier Source: org_study_id
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