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ENROLLING BY INVITATION
NCT06152991
PHASE3

Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy

Sponsor: Yoon Jun Kim

View on ClinicalTrials.gov

Summary

the purpose of this clinical trial is to assess the efficacy and safety of Orotic Acid Carnitine Complex Capsules (Godex®) in comparison to a placebo control group in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Comparative, Investigator-initiated Clinical Trial to Evaluate the Efficacy of Carnitine Orotate Complex _Godex® in Patients With Nonalcoholic Fatty Liver Disease

Key Details

Gender

All

Age Range

19 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2023-09-25

Completion Date

2027-02-26

Last Updated

2023-12-01

Healthy Volunteers

No

Interventions

DRUG

GODEX

The amount of active ingredient per dose (1 capsule) * Carnitine Orotate 150mg * liver extract antitoxic fraction 12.5㎎ * Adenine Hydrochloride 2.5mg * Pyridoxine Hydrochloride 25mg * Riboflavin 0.5mg * Cyanocobalamin 0.125mg * Biphenyl Dimethyl Dicarboxylate 25mg

DRUG

Placebo

* Anhydrous lactose 50mg. * Colloidal silicon dioxide 12mg. * Amorphous cellulose 50mg. * Lactose monohydrate 215.625mg. * Magnesium stearate 7mg. * Upper and lower brown opaque capsules 77mg.

Locations (1)

Seoul National University Hospital

Seoul, South Korea