CTRI/2022/12/048588已完成未知
A randomized, double blinded, placebo controlled, dose ranging, parallel group study to evaluate safety/tolerability and the efficacy of AMINO ACID SUPPLEMENTATION to improve liver function in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD).
Sundyota Numandis Probioceuticals Pvt. Ltd.0 个研究点目标入组 103 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female subjects between 20-50 years of age (both inclusive) with Non-Alcoholic fatty Liver Disease (Grade I & II).
- •2. Subject has provided written, signed and dated informed consent to participate in the study.
- •3. Subject is willing and able to comply with the protocol.
排除标准
- •1. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
- •2. Subject has a history of alcohol or other drug abuse in the past year.
- •3. Subject has a known allergy or sensitivity to any ingredient in the test product.
- •4. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •5. Investigator is uncertain about subjectâ??s capability or willingness to comply with the protocol requirements.
- •6. Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and alpha-1 antitrypsin deficiency).
- •7. Subjects with accidental cases like injury, all types of anemias.
- •8.Subjects with Hemophilia, Thalassemia, case of poisoning, alcoholic liver, Alcoholic chronic liver disease, Decompensated cirrhosis.
- •9. Chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson disease, deficits of alpha-1 antitrypsin, celiac disease.
- •10. Diseases, eczema, skin diseases/ allergy.
- •11.Malnutrition
- •12. Severe renal, cardiac or respiratory insufficiency.
- •13. Malignant tumors
- •14. Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass
- •15. Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil.
- •16. Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter).
- •17. Contraindication to liver biopsy.
- •18. Concomitant disease with reduced life expectancy.
- •19. Severe psychiatric conditions.
- •20. Pregnant and breast feeding women.
研究者
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