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IRCT20180903040941N1 IRCT 2019-06-03 Fasa University of Medical Sciences To evaluate effects of Matricaria chamomilla L. on patients with non alcoholic fatty liver disease The effect of Matricaria chamomilla L. on insulin resistance, inflammatory status and other related indices in patients with non-alcoholic fatty liver 2019-06-05 anticipated 44 Complete https://irct.ir/trial/33681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Random unit: Individual Randomization Tool: Random Numbers, Blinding description: Participants and researchers will not be aware of the study groups. Drug capsules and placebo capsules are also similar to each other and they are only labeled A and B. N/A non alcoholic fatty liver. Intervention 1: Intervention group: A capsule containing 500 mg of chamomile flower powder will be taken four times a day, two fasting morning and two nights before bedtime for three months. Intervention 2: Control group: placebo capsules containing roasted wheat flour plus 50 mg of chamomile powder will be taken four times a day, two fasting morning and two nights before bedtime for three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Sadegh amiri
Ibn Sina Square, Fasa University of Medical Sciences
Fasa Iran (Islamic Republic of) 86688-74616 +98 71 5331 6300 sadeghamiri2877@yahoo.com Fasa University of Medical Sciences scientific Dr Mohammad hashem hashempur
Ibn Sina Square, Fasa University of Medical Sciences
Fasa Iran (Islamic Republic of) 8668874616 +98 71 5331 6300 hashempur@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) 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. 25 years 65 years Both 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 K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: A capsule containing 500 mg of chamomile flower powder will be taken four times a day, two fasting morning and two nights before bedtime for three months. Control group: placebo capsules containing roasted wheat flour plus 50 mg of chamomile powder will be taken four times a day, two fasting morning and two nights before bedtime for three months. 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. 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. Fasa University of Medical Sciences Approved 2019-02-17 Ethics committee of fasa university of medical science Ibn Sina Square, Fasa University of Medical Sciences Fasa Fars Iran (Islamic Republic of)