Hepatic SteatosisPhase 2NCT06442137
A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease
A Phase 2 study testing Chazhu Xiaozhi decoction in people with Hepatic Steatosis and Symptoms and Signs, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatic Steatosis, Symptoms and Signs
- What is being tested?
- Chazhu Xiaozhi decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2024to 2 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:
- Age 18-50 years, both genders eligible;
- Meets the diagnostic criteria for NAFLD;
- Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
- Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
- Has not received any anti-NAFLD medication treatment in the past month;
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- 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;
- Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
- Voluntarily participates in the study and signs an informed consent form.
Who cannot join
- 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.);
- Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
- 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.;
- Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
- Known allergy or intolerance to any component of the study medication;
- Has participated in another clinical trial within the last three months;
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- Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
- Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
- Other conditions that the researcher considers unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
About this study
Official title: Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial
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.
Read more
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
- Being tested
- Chazhu Xiaozhi decoction, Control placebo
- Medical subject headings
- Fatty Liver, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chazhu Xiaozhi decoctionDrug
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 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | These medicines of Chazhu Xiaozhi decoction are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.
In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance. Receives: Drug: Chazhu Xiaozhi decoction |
| Control group | Placebo comparator | These placebo medicines are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.
In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance. Receives: Drug: Control placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 8 weeks
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.
Measured: through study completion, an average of 8 weeks
Secondary outcomes (10)
body weight
weighing on a scale
Measured: through study completion, an average of 8 weeks
body mass index
calculate
Measured: through study completion, an average of 8 weeks
fasting blood glucose
serum biochemistry
Measured: through study completion, an average of 8 weeks
alanine aminotransferase
serum biochemistry
Measured: through study completion, an average of 8 weeks
aspartate transaminase
serum biochemistry
Measured: through study completion, an average of 8 weeks
γ-glutamyl transpeptidase
serum biochemistry
Measured: through study completion, an average of 8 weeks
triglyceride
serum biochemistry
Measured: through study completion, an average of 8 weeks
total cholesterol
serum biochemistry
Measured: through study completion, an average of 8 weeks
creatinine
serum biochemistry
Measured: through study completion, an average of 8 weeks
urea nitrogen
serum biochemistry
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start17 Jul 2024
- Primary completion7 Nov 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442137
- Sponsor's protocol ID
- CXD20240523
- Other IDs
- 20234Y0142
- Status last verified
- Mar 2025
- First submitted
- 23 May 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06442137
- Acronym / sponsor ID
- CXD20240523
- Conditions
- Hepatic Steatosis, Symptoms and Signs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Chazhu Xiaozhi decoctionThese medicines of Chazhu Xiaozhi decoction are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks. In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance. |
| Control group | Placebo comparator | Drug: Control placeboThese placebo medicines are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks. In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:
- Age 18-50 years, both genders eligible;
- Meets the diagnostic criteria for NAFLD;
- Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
- Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
Key exclusion criteria (9 listed)
- 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.);
- Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
- 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.;
- Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
- Known allergy or intolerance to any component of the study medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chazhu Xiaozhi decoctionBelow 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 | Treatment group |
| Control placeboThe 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. | Drug | Control group |
Primary outcome
controlled attenuation parameter
Time frame: through study completion, an average of 8 weeks
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.
traditional Chinese medicine syndrome scale
Time frame: through study completion, an average of 8 weeks
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.
10 secondary outcomes
body weight
Time frame: through study completion, an average of 8 weeks
body mass index
Time frame: through study completion, an average of 8 weeks
fasting blood glucose
Time frame: through study completion, an average of 8 weeks
alanine aminotransferase
Time frame: through study completion, an average of 8 weeks
aspartate transaminase
Time frame: through study completion, an average of 8 weeks
γ-glutamyl transpeptidase
Time frame: through study completion, an average of 8 weeks
triglyceride
Time frame: through study completion, an average of 8 weeks
total cholesterol
Time frame: through study completion, an average of 8 weeks
creatinine
Time frame: through study completion, an average of 8 weeks
urea nitrogen
Time frame: through study completion, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chazhu Xiaozhi decoction in people with Hepatic Steatosis and Symptoms and Signs, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
controlled attenuation parameter (time frame: through study completion, an average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.