A prospective, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of Dose for your Liver (Dietary Supplement) in patients with Non-alcoholic Fatty Liver Disease (NAFLD)

Eetho Brands Inc0 sites30 target enrollmentTBD

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Sponsor: Eetho Brands Inc
Enrollment: 30
Status: Completed
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 25, 2021

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Eetho Brands Inc

•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).

•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.