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

Recruiting

Conditions: Fatty (change of) liver, not elsewhere classified,

Registration Number: CTRI/2021/11/037789

Lead Sponsor: NichiIn Bio Sciences Pvt Ltd

Brief Summary: **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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 12

Inclusion Criteria

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.
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.

Exclusion Criteria

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.

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(UAP	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.	2. For DM2 Cohort Only: Post Prandial Glucose: 140-199 mg/dL or greater than or equal to 30% reduction from baseline.

Trial Locations

Locations (2): Be Well Hospitals Private Limited
🇮🇳
Chennai, TAMIL NADU, India
Dedeepiyas Clinic
🇮🇳
Chennai, TAMIL NADU, India
Be Well Hospitals Private Limited
🇮🇳Chennai, TAMIL NADU, India
Dr CJ Vetrivel
Principal investigator
9841108873
drvetri@bewellhospitals.com