A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health

Vedic Lifesciences Pvt. Ltd.2 sites in 1 country60 target enrollmentOctober 6, 2022

ConditionsNon-Alcoholic Fatty Liver Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Non-Alcoholic Fatty Liver Disease
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 60
Locations: 2
Primary Endpoint: Fibroscan
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health

Registry

clinicaltrials.gov

Start Date

October 6, 2022

End Date

July 4, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years.
•CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II.
•Non-alcoholics (little or no consumption of alcohol).
•Willing to participate in the study with a signed and dated written consent.
•Overweight and obese participant with BMI more than or equal to 25 kg/m
•Having at least 3 of the following five metabolic risk factors:
•i Waist circumference: Men: more than or equal to102 cm (40.15 inches); Women more than or equal to 88 cm (34.65 inches).
•ii Triglycerides \>150 mg/dL. iii Blood pressure more than or equal to 130 mm Hg (systolic, SBP) and/or more than or equal to 85 mm Hg (diastolic, DBP).
•iv Fasting blood glucose more than or equal to 100 mg/ dl. v Low HDL level: Men: \< 40 mg/dL; Women: \< 50 mg/dL.

Exclusion Criteria

•Treatment of NAFLD for at least 3 months prior to the screening.
•History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
•Participants with liver cirrhosis, any concomitant liver disease.
•Participants with systemic inflammatory disease or autoimmune disorders.
•Participants with blood pressure Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP).
•Participants with Fasting blood glucose Less than or equal to 140 mg/ dl.
•Participants with cardiopulmonary disease.
•Heavy alcohol drinkers defined as follows:
•i For men, consuming more than 4 drinks on any day or more than 14 drinks/week ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
•Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.

Outcomes

Primary Outcomes

Fibroscan

Time Frame: Day 120.

To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo