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

Symptoms and Signs Clinical Trial

Official title:

Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442137
• Other study ID #: CXD20240523
• Secondary ID: 20234Y0142
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Shanghai Municipal Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:

1. Age 18-50 years, both genders eligible;

2. Meets the diagnostic criteria for NAFLD;

3. Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;

4. Has significant risk factors: CAP=238dB/m, Body Mass Index (BMI) =23 kg/m², Triglycerides =1.7 mmol/L;

5. Has not received any anti-NAFLD medication treatment in the past month;

6. Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;

7. Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;

8. Voluntarily participates in the study and signs an informed consent form.

Exclusion Criteria:

1. Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);

2. Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;

3. Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR < 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;

4. Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;

5. Known allergy or intolerance to any component of the study medication;

6. Has participated in another clinical trial within the last three months;

7. Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;

8. Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;

9. Other conditions that the researcher considers unsuitable for participation in this study.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Symptoms and Signs

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Municipal Hospital of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Municipal Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	controlled attenuation parameter	A liver fiber diagnostic instrument (Fibro Touch) is used to perform instantaneous elastic hardness testing. The controlled attenuation parameter usually represents liver fat content, whereas higher scores mean a worse outcome.	through study completion, an average of 8 weeks
Primary	traditional Chinese medicine syndrome scale	The traditional Chinese medicine syndrome scale includes evaluations of symptoms such as discomfort in the right flank, bloating in the epigastric region, bitter mouth, dry mouth, loose and loose stools, fatigue and fatigue throughout the body, loss of appetite, nausea, dizziness, and yellow urine, with a score range from 0 to 3, and higher scores mean a worse outcome.	through study completion, an average of 8 weeks
Secondary	body weight	weighing on a scale	through study completion, an average of 8 weeks
Secondary	body mass index	calculate	through study completion, an average of 8 weeks
Secondary	fasting blood glucose	serum biochemistry	through study completion, an average of 8 weeks
Secondary	alanine aminotransferase	serum biochemistry	through study completion, an average of 8 weeks
Secondary	aspartate transaminase	serum biochemistry	through study completion, an average of 8 weeks
Secondary	?-glutamyl transpeptidase	serum biochemistry	through study completion, an average of 8 weeks
Secondary	triglyceride	serum biochemistry	through study completion, an average of 8 weeks
Secondary	total cholesterol	serum biochemistry	through study completion, an average of 8 weeks
Secondary	creatinine	serum biochemistry	through study completion, an average of 8 weeks
Secondary	urea nitrogen	serum biochemistry	through study completion, an average of 8 weeks