NCT02983669

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

December 2, 2016

Last Update Submit

October 3, 2017

Conditions

Fatty LiverFatty Liver, Nonalcoholic

Keywords

Thymus PlantMultiflotriol [Supplementary Concept]Zataria multifloraComplementary TherapiesHerbal MedicineMedicine, traditional

Outcome Measures

Primary Outcomes (2)

  • Change in ALT (Alanin aminotransferase) level

    3 months

  • Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System

    3 months

Secondary Outcomes (8)

  • Change in AST (Aspartate aminotransferase) level

    3 months

  • Fasting blood sugar (FBS)

    3 months

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

    3 monyhs

  • Fasting insulin level

    3 months

  • Body weight

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Thyme

EXPERIMENTAL

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

Dietary Supplement: Thyme

Placebo

PLACEBO COMPARATOR

Wheat powder capsule 350 mg twice daily for 3 months

Other: Placebo

Interventions

ThymeDIETARY_SUPPLEMENT

Thyme capsule 350 mg twice daily

Also known as: Shirazi's Thyme
Thyme
PlaceboOTHER

Placebo capsule 350 mg twice daily

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Majid Nimruzi, MD

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

    PRINCIPAL INVESTIGATOR

  • Mojtaba Heydari, MD

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

    PRINCIPAL INVESTIGATOR

  • Nasrin dokht Zamani, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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 and Endocrinology

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

January 1, 2017

Primary Completion

April 20, 2017

Study Completion

May 10, 2017

Last Updated

October 4, 2017

Record last verified: 2017-10

Locations

IR(1)