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Completed

NCT Number: NCT02983669

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

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).

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Key information

Conditions

Fatty Liver Digestive System Diseases Fatty Liver, Nonalcoholic Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyme

Dietary Supplement

Thyme capsule 350 mg twice daily

Other names: Shirazi's Thyme

Placebo

Other

Placebo capsule 350 mg twice daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Acronym: ThymeLiv

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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