Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors

NCT06244550 | Completed

• 1 other identifier: TCHIRB-11002006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease globally, with an estimated prevalence of approximately 15 to 30%. The incidence of NAFLD is even higher, reaching up to 58%, in individuals who are overweight or obese. The pathogenesis of NAFLD is complex and not fully understood. The metabolism of carbohydrates contributes to the development of NAFLD, as it increases the enzymatic activity of lipid synthesis in the liver, depleting adenosine triphosphate (ATP) rapidly and causing stress on mitochondria and endoplasmic reticulum. The multifunctional protein Glycine N-methyltransferase (GNMT) plays a regulatory role in liver carbohydrate metabolism, and its expression is downregulated in the liver tissues of NAFLD. While weight loss and lifestyle adjustments are helpful in controlling NAFLD, effective pharmacological or healthcare interventions for NAFLD patients are currently lacking. Insulin resistance is crucial in the pathogenesis of NAFLD, suggesting that drugs improving insulin sensitivity, such as metformin, might have therapeutic effects. However, recent large-scale clinical trial results have not supported this hypothesis. Investigators propose that the mitochondrial inhibitory effects of metformin may be related to this discrepancy, and the negative effects may be reversed through food containing substances promoting GNMT gene expression, such as Ganwei (as know as "HepatoKeeper"). Preliminary animal experiments also show that the combined use of metformin and GNMT enhancers effectively eliminates liver lipid droplet accumulation and improves liver inflammation in a NAFLD mouse model, surpassing the effects of either drug used alone. Based on these findings, our team designed the medication treatment group for this clinical trial, aiming to investigate whether the combination of Ganwei and metformin produces a synergistic effect in humans. Ganwei compound herbal extract capsules contain extracts from natural foods such as Schisandra chinensis, Paeonia lactiflora, and Punica granatum. Among them, Paeonia lactiflora is known to contain components that enhance GNMT expression. Animal and cell experiments have demonstrated its potential for repairing liver damage and inflammation. This trial aims to assess the impact of orally administering Ganwei compound herbal extract capsules on participants and evaluate its effects on fatty liver, liver fibrosis, and metabolic indicators.

Conditions

Non-alcoholic Fatty Liver Disease; Liver Fibrosis; Liver Injury

Keywords

Ganwei; Non-alcoholic fatty liver disease; metformin

Outcome Measures

Primary Outcomes (2)

• Liver steatosis severity: the change of CAP (dB/m) by Fibroscan

  The effect of once daily, oral administration of 500 mg/15 kg of body weight Ganwei and/or 1500 mg metformin 24 weeks treatment versus before on the change in Controlled Attenuation Parameter(CAP) by FibroScan

  Week 24

• Liver fibrosis severity: the change of kPa by Fibroscan

  The effect of once daily, oral administration of 500 mg/15 kg of body weight Ganwei and/or 1500 mg metformin 24 weeks treatment versus before on the change in kPa by FibroScan

  Week 24

Secondary Outcomes (16)

• Aspartate Transaminase (AST)

  Week 24

• Alanine amino Transferase (ALT)

  Week 24

• Body mass index (BMI)

  Week 24

• Glycated Hemoglobin (HbA1c)

  Week 24

• White blood cell (WBC)

  Week 24

Study Arms (4)

Placebo + metformin

EXPERIMENTAL

Double blinded: matching placebo + metformin Placebo daily metformin 1500mg daily

Drug: Metformin; Drug: Placebo

Ganwei + metformin

EXPERIMENTAL

Double blinded: Ganwei + metformin Ganwei 500mg/15 kg of body weight, daily metformin 1500mg daily

Drug: Ganwei; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Double blinded: matching placebo Placebo daily

Drug: Placebo

Ganwei

EXPERIMENTAL

Double blinded: Ganwei Ganwei 500mg/15 kg of body weight, daily

Drug: Ganwei

Interventions

Ganwei DRUG

Capsules

Also known as: HepatoKeeper

Ganwei; Ganwei + metformin

Metformin DRUG

Tablets

Also known as: A10BA02

Ganwei + metformin; Placebo + metformin

Placebo DRUG

Matching capsules

Placebo; Placebo + metformin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be willing to participate in the study and provide written informed consent.
• Male and female adults ≥20 and \<80 years of age.
• Suspected or confirmed diagnosis of NAFLD:
• Fibroscan with CAP ≥220 dB/m
• Criteria for diagnosing fatty liver: Abdominal ultrasound reveals differences in liver and kidney parenchyma due to wave reflection, liver parenchymal ultrasound attenuation, and blurred imaging of liver vessels and diaphragm, indicating fatty liver.

You may not qualify if:

• Female patients who are pregnant or breastfeeding.
• Diabetic patients undergoing medication treatment.
• Patients clinically diagnosed with alcoholic hepatitis, autoimmune hepatitis, or biliary liver disease.
• Excessive alcohol consumption (more than 15 grams/day for females, more than 30 grams/day for males).
• Users of weight-loss products and vitamin E supplements.
• Individuals with an estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73m².

Sponsors & Collaborators

• Taipei City Hospital: lead
• The One Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Taipei City Hospital

Taipei, 103212, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Chih-Lin Lin, MD.

  Department of Gastroenterology, Renai branch, Taipei City Hospital, Taipei, Taiwan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: September 22, 2021
• Primary Completion: March 14, 2023
• Study Completion: June 13, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

TW (1)