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

Phase 2

Completed

Brief Summary: The current study is designed as a prospective, randomized, double-blind, placebo-controlled, parallel group study in male and non-pregnant female patients with NAFLD. This study involves a screening phase, randomization and treatment phase, and follow-up phase as mentioned below:

Screening phase (Visit 1): -14 days to -1 day

Day of randomization (Visit 2): Day 0

Initiation of treatment: Day 1

Interim follow up visit (Visit 3): Day 31 Â±2 days

End of treatment (Visit 4): Day 61 Â±2 days

End of study (telephonic safety call): Day 67 Â±2 days

Treatment phase: 60 Days

Patients considered eligible will be randomized and enter into treatment phase. A total of 30 patients will be enrolled in the study in a randomization ratio of 1:1 to receive test and its matching placebo products, respectively.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent prior to any study-related activities being performed.
Able and willing to comply with the protocol, including availability for all scheduled study visits.
Male and Female patients aged between 18 years to 70, both inclusive.
Patients diagnosed with fatty liver (grades 1-3) based on liver USG.
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.
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

Hypersensitivity to contents of Dose for your Liver or related class of drugs or to any of the excipients of the formulation.
Fatty liver secondary to alcohol consumption.
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.
Addicted Alcoholics and- or drug abusers.
History or presence of coronary, renal, pulmonary and thyroid disease.
AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microleter.
Difficulty in swallowing and retaining oral formulation.
Known HBsAg positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha-1 antitrypsin deficient patients.
Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
Patient has condition or is in a situation which, in the investigatorâ€™s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patientâ€™s participation in the study.
Participation in any other clinical study within 30 days before the first dose of Investigational Product.
Pregnant or Lactating female patient.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in fatty liver grading based on liver USG	AST to Platelet Ratio Index (APRI)
Safety Outcome: Number and types of adverse (AEs) and serious adverse events (SAEs)	from baseline to day 67

Locations (1): Sanjivani Super Speciality Hospital Pvt. Ltd.
🇮🇳
Ahmadabad, GUJARAT, India
Sanjivani Super Speciality Hospital Pvt. Ltd.
🇮🇳Ahmadabad, GUJARAT, India
Dr Jignesh Patel
Principal investigator
9727735536
drjigs2712@gmail.com