Effect of saffron on inflammatory and antioxidant factors in patients with fatty liver disease
- Conditions
- non alcoholic fatty liver disease.Fatty (change of) liver, not elsewhere classified
- Registration Number
- IRCT201705309472N13
- Lead Sponsor
- Deputy of Research of Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
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-a)
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method