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IRCT201705309472N13 IRCT 2017-07-26 Deputy of Research of Iran University of Medical Sciences Effect of saffron on inflammatory and antioxidant factors in patients with fatty liver disease Effect of saffron powder on serum concentration of hs-CRP, TNF-α, MDA, TAC, adiponectin and leptin in patients with non-alcoholic fatty live disease 2017-02-18 anticipated 76 Complete https://irct.ir/trial/10060 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 non alcoholic fatty liver disease. Intervention 1: Saffron powder group: One day, one tablet will contain 100 mg of saffron for 3 months (12 weeks). Intervention 2: Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg dextrose malto.
public Dr naheed aryaeian
Shahid Hemmat Highway intersection of Sheikh Fazlollah and Shahid Chamran Iran University of Medical Sciences School of Public Health
tehran Iran (Islamic Republic of) +98 21 8877 9118 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr naheed aryaeian
Shahid Hemmat highway, intersection of Sheikh Fazlollah and Shahid Chamran, Iran University of Medical Sciences, School of Public Health
tehran Iran (Islamic Republic of) +98 21 8877 9118 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria 1- Age 18 to 65 years 2. Both sexes 3. Detection of non-alcoholic fatty liver by an expert physician based on the high levels of ALT, AST enzymes >=30U / L in men and> 19U/L in women) and liver transcription 4. Desire to participate in studying and signing conscientious intention Non-inclusion criteria: (exclusion criteria) 1- Pregnancy and lactation or planning pregnancy 2- Use an antioxidant supplement or any nutritional supplement within one month before sampling 3. Acute heart disease, kidney, thyroid, diabetes, infections, hepatitis B and C and other liver diseases (diagnosed by a specialist) and diseases that affect the weight (hyperprolactinemia, Cushing's syndrome) 4. Have a high-gain or weight loss regimen within 3 months prior to sampling 5- Using effective drugs on weight, fatty liver and insulin resistance during 3 months before sampling (hormonal, antidepressant, anti-psychotics) 6- Use of drugs that are probably related to NAFLD: 7- (valporic acid, tetracycline, systematic glucocorticoid, methotrexate amidarone, anabolic steroids, estrogen, tamoxifen or other known hepatotoxic drugs) Exit criteria: 1. Unwillingness to continue cooperation in research 2- Initiating the use of anti-NASH drugs (thiazolidindiones, vitamin E, betaine, milk thistle, UDCA, SAM-E, gemfibrozil, probiotic, anti-TNF-α) 3. Start using any type of nutritional supplement and anti-inflammatory drugs 4. Cure for diseases that require special treatments that interfere with the intervention. 5- Pregnancy during the study 6- Patients whose compliance and consumption of saffron powder or placebo by them is less than 80% recommended by the host. 18 years 65 years Both K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Saffron powder group: One day, one tablet will contain 100 mg of saffron for 3 months (12 weeks). Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg dextrose malto. Hs-crp. Timepoint: Before intervention and 3 months after intervention. Method of measurement: ELISA kit in ng / ml. ALT. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric. AST. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric. Waist to hip ratio (WHR). Timepoint: Before the intervention and three months after the intervention. Method of measurement: calculation. TNF-a. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in pg / ml. TAC. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L. Adiponectin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml. Leptin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml. Malondialdehyde (MDA). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Colorimetric method ng / ml. Weight. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Digital scale in kilograms. Body mass index (BMI). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Calculation / in kg / m2. Waist. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm. Hip circumference. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm. Body fat percentage. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ebody device BIA method. Deputy of Research of Iran University of Medical Sciences Approved 2017-02-19 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway intersection of Sheikh Fazlollah and Shahid Chamran Iran University of Medical Sciences tehran Iran (Islamic Republic of)