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A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease

NCT06442137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Chazhu Xiaozhi decoction. The main questions it aims to answer are:

Does drug Chazhu Xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? What medical problems do participants have when taking drug Chazhu Xiaozhi decoction? Researchers will compare drug Chazhu Xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease.

Participants will:

Take drug Chazhu Xiaozhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment

Conditions

  • Hepatic Steatosis
  • Symptoms and Signs

Interventions

DRUG

Chazhu Xiaozhi decoction

Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.

DRUG

Control placebo

The control placebo is a ten-fold dilution of the Chazhu Xiaozhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.

Sponsors & Collaborators

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2024-11-07
Completion
2025-01-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442137 on ClinicalTrials.gov