A clinical study of Dose for your Liver (Dietary Supplement) in patients with Non-alcoholic Fatty Liver Disease

Phase 2

Completed

• Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

• Registration Number: CTRI/2021/08/035359
• Lead Sponsor: Eetho Brands Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Willing and able to provide written informed consent prior to any study-related activities being performed.

2. Able and willing to comply with the protocol, including availability for all scheduled study visits.

3. Male and Female patients aged between 18 years to 70, both inclusive.

4. Patients diagnosed with fatty liver (grades 1-3) based on liver USG.

5. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.

6. Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation).

Exclusion Criteria

1. Hypersensitivity to contents of Dose for your Liver or related class of drugs or to any of the excipients of the formulation.

2. Fatty liver secondary to alcohol consumption.

3. History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink is equal to 5 ounce (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within the previous 6 months from screening.

4. Addicted Alcoholics and- or drug abusers.

5. History or presence of coronary, renal, pulmonary and thyroid disease.

6. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microleter.

7. Patients using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization.

8. Difficulty in swallowing and retaining oral formulation.

9. Known HBsAg positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha-1 antitrypsin deficient patients.

10. Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.

11. Patient has condition or is in a situation which, in the investigatorââ?¬•s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patientââ?¬•s participation in the study.

12. Participation in any other clinical study within 30 days before the first dose of Investigational Product.

13. Pregnant or Lactating female patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients showing improvement in fatty liver grading from baseline based on liver USGTimepoint: from baseline to day 60

Secondary Outcome Measures

Name	Time	Method
Change in fatty liver grading based on liver USG <br/ ><br>AST to Platelet Ratio Index (APRI) <br/ ><br>Change in CAP score based on Fibroscan <br/ ><br>Change in lipid profile and liver enzymes ALT and AST <br/ ><br>Timepoint: from baseline to day 60;Safety Outcome: Number and types of adverse (AEs) and serious adverse events (SAEs)Timepoint: from baseline to day 67