Clinical trial NCT02983669: The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Fatty Liver, Nonalcoholic
Keywords: Thymus Plant
Multiflotriol [Supplementary Concept]
Zataria multiflora
Complementary Therapies
Herbal Medicine
Medicine, traditional
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Change in ALT (Alanin aminotransferase) level
timeFrame: 3 months
measure: Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
timeFrame: 3 months
Secondary outcomes:
measure: Change in AST (Aspartate aminotransferase) level
timeFrame: 3 months
measure: Fasting blood sugar (FBS)
timeFrame: 3 months
measure: Change in Gama GT (γ-glutamyl transpeptidase) level
timeFrame: 3 monyhs
measure: Fasting insulin level
timeFrame: 3 months
measure: Body weight
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
measure: Hip circumference
timeFrame: 3 months
measure: Number of patients with adverse events
timeFrame: 4 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Majid Nimruzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Mojtaba Heydari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Nasrin dokht Zamani, MD
role: PRINCIPAL_INVESTIGATOR
References: