Clinical Study on Two Strains of Nichi Glucan AFO-202 and N-163 in NAFLD

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Translent Elastography(TE) : Improvement in fatty liver based on reduction in Ultrasound Attenuation Parameter(UAPTimepoint: 1. Translent Elastography(TE) : Day 1, Day 30 and Day 60.

Secondary Outcome Measures

Name	Time	Method
1. For DM2 Cohort Only: Fasting Blood Glucose: 70-125 mg/dL or greater than or equal to 10% reduction from baseline. <br/ ><br>2. For DM2 Cohort Only: Post Prandial Glucose: 140-199 mg/dL or greater than or equal to 30% reduction from baseline. <br/ ><br>3. For DM2 Cohort Only: HbA1C: 5.7-6.4% A1C levels. <br/ ><br>4. For DM2 Cohort Only: HbA1C: lesser than 5.7% A1C levels. <br/ ><br>5. Fasting Lipid Profile: Greater than or equal to 30%improvement. <br/ ><br>6. Safety Investigations: hsCRP, Complete Blood Count. <br/ ><br>Timepoint: 1. For DM2 Cohort Only: Fasting Blood Glucose: Day 1, Day 30 and Day 60. <br/ ><br>2. For DM2 Cohort Only: Post Prandial Glucose: Day 1, Day 30 and Day 60. <br/ ><br>3. For DM2 Cohort Only: HbA1C: Day 1, Day 30 and Day 60. <br/ ><br>4. For DM2 Cohort Only: HbA1C: Day 1, Day 30 and Day 60. <br/ ><br>5. Fasting Lipid profile: Day 1, Day 30 and Day 60. <br/ ><br>6. Safety Investigation: hsCRP, Complete Blood Count: Day 1, Day 30 and Day 60. <br/ ><br>