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| ID | Type | Description | Link |
|---|---|---|---|
| 20234Y0142 | Other Grant/Funding Number | Shanghai Municipal Health Commission |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chazhu Xiaozhi decoction | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | weighing on a scale | through study completion, an average of 8 weeks |
| body mass index | calculate | through study completion, an average of 8 weeks |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Municipal Hospital of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200071 | China |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants are assigned to one of two groups in parallel for the duration of the study
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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. An independent researcher (not involved in the trial operations or evaluations) is responsible for managing the randomization sequence and drug coding, and will distribute the appropriate drugs to participants at the right times. This ensures that the trial operators and evaluators are unaware of the treatment type; only the independent researcher has this knowledge. During the experiment, the assessment of treatment effects and the recording of adverse events are carried out by independent evaluators who are unaware of the treatment groups. Both the trial operators and the evaluators do not have access to the drug coding and randomization sequence.
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| Control placebo | Drug | 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. |
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| fasting blood glucose | serum biochemistry | through study completion, an average of 8 weeks |
| alanine aminotransferase | serum biochemistry | through study completion, an average of 8 weeks |
| aspartate transaminase | serum biochemistry | through study completion, an average of 8 weeks |
| γ-glutamyl transpeptidase | serum biochemistry | through study completion, an average of 8 weeks |
| triglyceride | serum biochemistry | through study completion, an average of 8 weeks |
| total cholesterol | serum biochemistry | through study completion, an average of 8 weeks |
| creatinine | serum biochemistry | through study completion, an average of 8 weeks |
| urea nitrogen | serum biochemistry | through study completion, an average of 8 weeks |