NCT02289235

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
4.5 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

November 7, 2014

Last Update Submit

October 17, 2020

Conditions

Fatty LiverDiabetes Mellitus, Type 2

Keywords

GingerMedicine, traditionalHerbal medicine

Outcome Measures

Primary Outcomes (2)

  • Change in ALT (liver transaminases) level

    Change in the concentration of ALT (liver transaminases)

    Baseline and 3 months

  • Change in score of fatty liver in fibroscan

    Change in score of fatty liver in fibroscan (elastography)

    Baseline and 3 months

Secondary Outcomes (3)

  • Change in AST (liver transaminases) level

    Baseline and 3 months

  • Change in Gama GT (γ-glutamyl transpeptidase) levels

    Baseline and 3 months

  • Number of patients with adverse events

    4 months

Study Arms (2)

Ginger

EXPERIMENTAL

Ginger powder capsule 500 mg

Drug: Ginger

Placebo

PLACEBO COMPARATOR

Placebo powder capsule

Drug: Placebo

Interventions

GingerDRUG

Ginger powder capsule 1000 mg twice daily for 3 months

Ginger
PlaceboDRUG

Placebo powder 2 capsules twice daily for 3 months

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Fatty LiverDiabetes Mellitus, Type 2

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mesbah Shams, M.D.

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    STUDY CHAIR

  • Majid Nimruzi, M.D.

    Research Center for Traditional Medicine, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Kamran Bagheri Lankarani, M.D.

    Health policy Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Parisa-sadaat Ghoreishi, M.D.

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal Medicine & Endocrinology

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 13, 2014

Study Start

May 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)