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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 1. Translent Elastography(TE) : Improvement in fatty liver based on reduction in Ultrasound Attenuation Parameter(UAP
研究概览
简要总结
Study Design : An Open Label, Prospective, Randomised, Comparative, Two ArmClinical Study Indication : NAFLD InvestigationalProduct : NichiGlucan AFO-202 and N-163 Comparator: None. Conventional Therapyconsidered as control Dose/Dosage: Nichi Glucan AFO-202 and N-163. 1 sachet of NichiGlucan AFO-202 and N-163 to be consumed with water 30 minutes after meal SubjectPopulation: 12 Number ofSubjects: 12 Evaluable Subjects Treatment Arms:Two Treatment Arms Treatment ArmI: ConventionalTherapy Treatment ArmII: Nichi GlucanAFO-202 and N-163 plus Conventional Therapy TreatmentDuration: 60 Days
Assessments 1. TranslentElastography(TE) : Day 1, Day 30 and Day 60. 2. For DM2 CohortOnly: Fasting Blood Glucose: Day 1, Day 30 and Day 60. 3. For DM2 CohortOnly: Post Prandial Glucose: Day 1, Day 30 and Day 60. 4. For DM2 CohortOnly: HbA1C: Day 1, Day 30 and Day 60. 5. For DM2 CohortOnly: HbA1C: Day 1, Day 30 and Day 60. 6. Fasting Lipidprofile: Day 1, Day 30 and Day 60. 7. SafetyInvestigation: hsCRP, Complete Blood Count: Day 1, Day 30 and Day 60.
**Background ofthe study:**Fattyliver is a common condition caused by having too much fat build up in yourliver. A healthy liver contains a small amount of fat, it becomes a problemwhen fat reaches 5% to 10% of livers weight. There is no medication specificallyfor fatty liver but lifestyle changes that can significantly improve yourhealth. An alternative treatment with nutritional supplements with higher levelof safety and effectiveness are needed.
Purpose of theStudy : Nichi Glucan is a food supplement it containstwo variants one from strain AFO-202 and other from strain-163.Nichi Glucan hasa unique structural formula compared to other 1,3-1,6 Beta glucans. Based onits effects maintaining blood glucose and lipid levels and also fatty liverdiseases. This clinical study is done to evaluatethe safety, efficacy and tolerability of Two Strains of Nichi Glucan AFO-202 and N-163 as an Addon Therapy in Comparison with Conventional Therapeutic Regimen in Adultsubjects with NAFLD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects aged between 18 and 55 years both ages, all sexes inclusive diagnosed with NAFLD
- •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.
- •Subjects who have no history of substance abuse specifically alcohol.
- •Subjects who dont consume alcoholic beverages-Men more than 4 per day pr 17 per week;Women-3 per day or 7 per week.
- •Subjects may have diabetes mellitus.
- •Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •Subjects with history that suggests possible allergic reaction to the investigational product.
- •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.
- •Subjects with AST, ALT 5 times ULN.
- •Subjects who have undergone surgical procedures on the liver, not limited to liver transplant, liver resection, hepatic lobotomy.
- •Subjects with billary duct obstruction on the basis of ultrasound.
- •Subjects with a history of gastrointestinal bypass or current use of drugs known to cause hepatic steatosis eg., aminodarone, valproate, tamoxifen, methotrexate, steroids etc.
- •Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible.
- •Subjects who have undergone major surgical procedure 4 weeks prior to randomization.
- •Subjects with history or current diagnosis or autoimmune diseases, immunocompromised states.
- •Subjects with CKD or other diseases that impair normal kidney function.
- •Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interferen with the parameters of the clinical study.
- •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.
- •Females who are pregnant or lactating or planning to become pregnant during the study period.
- •Subjects who are currently participating or have participated in a clinical trial upto 90days prior to randomization.
- •Subjects, who in the opinion of the investigator are unsuitable for enrolment.
结局指标
主要结局
1. Translent Elastography(TE) : Improvement in fatty liver based on reduction in Ultrasound Attenuation Parameter(UAP
时间窗: 1. Translent Elastography(TE) : Day 1, Day 30 and Day 60.
次要结局
- 1. For DM2 Cohort Only: Fasting Blood Glucose: 70-125 mg/dL or greater than or equal to 10% reduction from baseline.(2. For DM2 Cohort Only: Post Prandial Glucose: 140-199 mg/dL or greater than or equal to 30% reduction from baseline.)