Hepatobiliary diseases (damp heat syndrome of liver and gallbladder)
Conditions
Interventions
experimental group:On the basis of conventional treatment, take Yindan Pinggan Capsules additionally.
Sponsors
Beijing Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for the syndrome of dampness-heat in the liver and gallbladder. (2) Clinically diagnosed with chronic hepatitis B, non-alcoholic fatty liver disease, alcoholic liver disease, or chronic cholecystitis. (3) Subjects have the following characteristics: 1) For subjects with chronic hepatitis B, they are either treatment-naive subjects or previously treated subjects, and ALT and/or AST are greater than the upper limit of normal values. 2) For subjects with non-alcoholic fatty liver disease or alcoholic liver disease, they must meet a and at least one of b/c: a. At least one of ALT, AST, and ?-GT is between 1.2 and 5 times (including both end values) the upper limit of normal values; b. Abdominal B-ultrasound indicates diffuse fatty liver; c. MRI-PDFF = 8%. 3) For subjects with chronic cholecystitis, their condition is stable during screening, they can receive drug treatment, the VAS score of right upper abdominal pain (distending pain or discomfort) is = 40mm during the screening period, and right upper abdominal B-ultrasound indicates chronic cholecystitis. (4) Aged between 18 and 75 years old, regardless of gender. (5) Willing to participate in this clinical trial, informed consent is obtained and the informed consent form is signed.
Exclusion criteria
Exclusion criteria: (1) Patients with spleen and stomach deficiency-cold syndrome (mainly characterized by early satiety, general fatigue, and cold hands and feet); (2) Those with complete obstruction of the biliary tract; (3) Patients who have taken medications similar to the indications described in the instructions for Yin Dan Ping Gan Capsules within the past 2 weeks; (4) Individuals with serious heart, brain, liver, kidney, blood, metabolic, and endocrine system diseases, as assessed by the researchers to be unsuitable for participation in the study, including those with tumors and mental illnesses; (5) Participants who have participated in other interventional drug clinical trials within the past 3 months; (6) Those known to be allergic to the trial medication or its components; (7) Pregnant women or breastfeeding mothers, or subjects planning to conceive within the next 6 months (including partners); (8) Individuals with mental disorders or lacking autonomous decision-making abilities, etc.; (9) Subjects deemed unsuitable for the study by the researcher, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with normalized liver function indexes after treatment (chronic hepatitis B, non - alcoholic fatty liver disease, alcoholic liver disease);The response rate of right upper quadrant pain (distending pain or discomfort) symptoms at the end of 8 weeks of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in liver function test indicators after treatment compared to the baseline (chronic hepatitis B, non - alcoholic fatty liver disease, alcoholic liver disease);Changes in blood lipids after treatment compared to baseline (non - alcoholic fatty liver disease, alcoholic liver disease);Changes in liver fat content (MRI-PDFF) from baseline after treatment (non-alcoholic fatty liver disease, alcoholic liver disease);Changes in baseline of body mass index (BMI) and waist-hip ratio (non-alcoholic fatty liver disease, alcoholic liver disease);Changes in FIB-4 compared to the baseline (non-alcoholic fatty liver disease, alcoholic liver disease);The change value and change rate of VAS score for pain (distending pain or discomfort) in the right upper abdomen after medication compared to the baseline (chronic cholecystitis);Efficacy of abdominal gallbladder color ultrasound after treatment (chronic cholecystitis);Changes in TCM symptom scores/single symptom scores after treatment compared to the baseline (total);Efficacy Evaluation of Traditional Chinese Medicine Syndromes after Treatment (General); | — |
Countries
China
Contacts
Public ContactChunjun Xu
Beijing Hospital of Traditional Chinese Medicine
Outcome results
None listed