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To evaluate effects of Matricaria chamomilla L. on patients with non alcoholic fatty liver disease

Not Applicable
Recruiting
Conditions
non alcoholic fatty liver.
Fatty (change of) liver, not elsewhere classified
K76.0
Registration Number
IRCT20180903040941N1
Lead Sponsor
Fasa University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
44
Inclusion Criteria

sign the consent form
age between 25-65 years
BMI between 22-35
Diagnosis of fatty liver and steatohepatitis with: A- serum level of Alanine Transaminease (ALT) More than one and a half times the highest normal limit(66/5000This means that more than 45 men and women more than or equal to 29 units per liter)Also, the amount of aspartate transaminase (AST) In both sexes is greater than 30 units per liter(According to the latest definition of ALT and abnormal AST in men and women). B- Diagnosis of fatty liver (moderate to high) in liver ultrasound.
The patient have not to consume lipid regulating drugs for four weeks
The patient have not to consume some drugs like silybin, ursodeoxycholic acid, Polyene Phosphatidylcholine, vitamin E and Medicinal herbs with blood lipid regulation effect and hepatoprotective effect from four weeks bfore entering to the study.

Exclusion Criteria

pregnancy and lactation
Liver failure (acute or chronic)
Liver diseases such as autoimmune hepatitis, viral hepatitis B and C (active or inactive), Wilson's disease and etc.
Hypo and hyperthyroidism
Renal failure (creatinine above 1.5 mg / dL)
Any malignancy (treated or not)
Taking warfarin
Addiction and alcohol consumption
Taking contraceptives, ouroso-doxycyclic acid, glucocorticoid, statins, probiotics, vitamin E over the past three months
Chamomile allergy history

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fatty liver grade. Timepoint: Initially and three months later. Method of measurement: Ultrasound.;Hepatic aminotransferases. Timepoint: Initially and six weeks later and three months later. Method of measurement: Laboratory Kit.;Fatty liver index(FLI). Timepoint: Initially and three months later. Method of measurement: Using formula: [e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745) / (1 + e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745)] × 100.;Alpha Tumor Necrosis Factor. Timepoint: Initially and three months later. Method of measurement: Laboratory Kit.;Insulin resistance index. Timepoint: Initially and three months later. Method of measurement: Calculate the HOMA-IR.;Alkaline phosphatase. Timepoint: initially and three months later. Method of measurement: Laboratory Kit.
Secondary Outcome Measures
NameTimeMethod
Body mass composition. Timepoint: At the entrance and three months later. Method of measurement: Body mass composition machine.;Inflammation. Timepoint: At the entrance and three months later. Method of measurement: hs-CRP labratory kit.;Lipide profile. Timepoint: At the entrance and three months later. Method of measurement: Blood test.
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