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The goal of this clinical trial is to learn if Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Longqi Jiangzhi decoction. Researchers will compare drug Longqi Jiangzhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease. Participants will: Take drug Longqi Jiangzhi 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 Longqi Jiangzhi 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 |
|---|---|---|---|---|
| Longqi Jiangzhi decoction | Drug | Below is the composition of Longqi Jiangzhi decoction: Gentiana Scabra 5g, Astragalus membranaceus 10g, Rhizoma Alismatis 10g, Crataegus pinnatifida 10g, Citri Reticulatae Pericarpium 5g. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | weighing on a scale | through study completion, an average of 8 weeks |
| total cholesterol | serum biochemistry | through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| urea nitrogen | serum biochemistry | through study completion, an average of 8 weeks |
| creatinine | serum biochemistry | through study completion, an average of 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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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 Longqi Jiangzhi 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.
| Control placebo | Drug | The control placebo is a ten-fold dilution of the Longqi Jiangzhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug. |
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| triglyceride | serum biochemistry | through study completion, an average of 8 weeks |
| fasting plasma glucose | serum biochemistry | through study completion, an average of 8 weeks |
| alanine aminotransferase | serum biochemistry | through study completion, an average of 8 weeks |
| aspartate aminotransferase | serum biochemistry | through study completion, an average of 8 weeks |