CTRI/2021/11/037789招募中未知
An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Two Strains of Nichi Glucan AFO-202 and N-163 as an Add on Therapy in Comparison with Conventional Therapeutic Regimen in Adult Subjects with NAFLD.
ichiIn Bio Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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. Adult subjects aged between 18 and 55 years both ages, all sexes inclusive diagnosed with NAFLD
- •2. Subjects with NAFLD Activity Score greater than or equal to 3 and FIB-4 cut offs of greater than 1.3 and less than 3.25 as diagnosed by USG.
- •3. Subjects who have no history of substance abuse specifically alcohol.
- •4. Subjects who dont consume alcoholic beverages-Men more than 4 per day pr 17 per week;Women-3 per day or 7 per week.
- •5. Subjects may have diabetes mellitus.
- •6. Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
- •7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1. Subjects with history that suggests possible allergic reaction to the investigational product.
- •2. Subjects who have a history or an active diagnosis of any hepatic infection not limited to Hepatocellular Carcinoma, HCV, HBV, congenital or liver disease of any etiology.
- •3. Subjects with AST, ALT 5 times ULN.
- •4. Subjects who have undergone surgical procedures on the liver, not limited to liver transplant, liver resection, hepatic lobotomy.
- •5. Subjects with billary duct obstruction on the basis of ultrasound.
- •6. Subjects with a history of gastrointestinal bypass or current use of drugs known to cause hepatic steatosis eg., aminodarone, valproate, tamoxifen, methotrexate, steroids etc.
- •7. Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible.
- •8. Subjects who have undergone major surgical procedure 4 weeks prior to randomization.
- •9. Subjects with history or current diagnosis or autoimmune diseases, immunocompromised states.
- •10. Subjects with CKD or other diseases that impair normal kidney function.
- •11. Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interferen with the parameters of the clinical study.
- •12. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
- •13. Females who are pregnant or lactating or planning to become pregnant during the study period.
- •14. Subjects who are currently participating or have participated in a clinical trial upto 90days prior to randomization.
- •15. Subjects, who in the opinion of the investigator are unsuitable for enrolment.
研究者
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