Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease (ThymeLiv)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02983669
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, Shiraz University of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Fatty Liver Fatty Liver, Nonalcoholic Dietary Supplement: Thyme Other: Placebo Not Applicable

Detailed Description:
In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Actual Study Start Date : January 2017
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : May 10, 2017


Arm Intervention/treatment
Experimental: Thyme
Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months
Dietary Supplement: Thyme
Thyme capsule 350 mg twice daily
Other Name: Shirazi's Thyme

Placebo Comparator: Placebo
Wheat powder capsule 350 mg twice daily for 3 months
Other: Placebo
Placebo capsule 350 mg twice daily




Primary Outcome Measures :
  1. Change in ALT (Alanin aminotransferase) level [ Time Frame: 3 months ]
  2. Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in AST (Aspartate aminotransferase) level [ Time Frame: 3 months ]
  2. Fasting blood sugar (FBS) [ Time Frame: 3 months ]
  3. Change in Gama GT (γ-glutamyl transpeptidase) level [ Time Frame: 3 monyhs ]
  4. Fasting insulin level [ Time Frame: 3 months ]
  5. Body weight [ Time Frame: 3 months ]
  6. Waist circumference [ Time Frame: 3 months ]
  7. Hip circumference [ Time Frame: 3 months ]
  8. Number of patients with adverse events [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983669


Locations
Layout table for location information
Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Mesbah Shams, MD, Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02983669     History of Changes
Other Study ID Numbers: 94-7648
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mesbah Shams, MD, Shiraz University of Medical Sciences:
Thymus Plant
Multiflotriol [Supplementary Concept]
Zataria multiflora
Complementary Therapies
Herbal Medicine
Medicine, traditional

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases