Chronic calculous cholecystitis
Conditions
Interventions
Positive control group:Use Danshitong Capsules treatment
placebo group:Use Danshitong Capsules placebo and Jinqian Dantong granules
Test group:Jinqian Dantong granules treatment
Sponsors
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ) Meets the diagnostic criteria for chronic calculous cholecystitis; (2) Meets the traditional Chinese medicine syndrome differentiation criteria for damp heat stagnation; (3) Chronic cholecystitis with stones is stable and can be treated with medication; (4) Right flank or upper right abdominal pain VAS score = 3 points = 6 points; (5) 18 = Age = 65 years old; (6) Voluntarily sign the informed consent form for clinical trials.
Exclusion criteria
Exclusion criteria: 1) Individuals with a history of acute exacerbation of chronic cholecystitis within one week prior to enrollment; (2) Patients with axillary temperature = 38.5 ° C and white blood cell count exceeding 1.2 times the upper limit of normal values; (3) Confirmed through examination as having intrahepatic stones liver abscess chronic hepatitis gastrointestinal tumors gastrointestinal ulcers hiatal hernia chronic pancreatitis and functional dyspepsia which may cause right flank or upper right abdominal pain; (4) Patients with wind cold cough or prolonged cough due to physical deficiency chronic diarrhea and myasthenia gravis; (5) Those who meet the surgical indications for chronic cholecystitis or plan to undergo surgical treatment within 3 months; (6) Within one week prior to enrollment take Chinese and Western medications for the treatment of this disease including antibiotics anti stone drugs etc; (7) Those with severe circulatory respiratory urinary endocrine (including diabetes and poor control) blood system diseases malignant tumors and mental and neurological disorders who cannot cooperate ALT AST = 2 times the upper limit of normal value and Scr>the upper limit of normal value; (8) Individuals with allergic constitution or allergies to the ingredients of experimental drugs; (9) Alcoholic and drug abusers and drug addicts; (10) Pregnancy (women of childbearing age with positive pregnancy test results) those preparing for pregnancy and lactation; (11) Individuals who have participated in other clinical trials within the past month or are currently undergoing such trials; (12) Researchers determine that participants are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive score for right flank or upper right abdominal pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in duration of pain;Comprehensive therapeutic effect of diseases;Changes in the number/diameter of gallstones;Change in Pain Severity Score;Changes in gallbladder wall thickness;Effective rate of traditional Chinese medicine syndrome;Changes in bilirubin levels from baseline;Pain disappearance time;Change in frequency of abdominal pain attacks; | — |
Countries
CHINA
Contacts
Public ContactShengsheng Zhang
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Outcome results
None listed