Chronic cholecystitis
Conditions
Interventions
Trial groups:3 pellets each time, 3 times a day
control group:3 pellets each time, 3 times a day
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of chronic cholecystitis in western medicine; 2. Those who met the syndrome differentiation criteria of hepatobiliary dampness and heat syndrome in traditional Chinese medicine; 3. Those with stable disease at screening who are acceptable for medication; 4. Right upper quadrant pain (flatulence or discomfort) during the lead-in phase vas mean score was between 40mm-80mm (encompassing both ends); 5. Age 18 years (inclusive) to 65 years (inclusive), sex unlimited; 6. Agreed to participate in this clinical trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute obstructive purulent cholangitis, gallbladder perforation complicated by diffuse peritonitis, gallbladder neoplasms, gallbladder polyps or stones requiring surgery; 2. Those with serum amylase higher than 3 times the upper limit of normal; 3. Those with combined clinically significant renal and ureteral stones; 4. Satisfied the following three items simultaneously: body temperature (axillary temperature) >= 37.5 ?, white blood cell (WBC) > 11.0 x 10^9 / L, neutrophil percentage (NE%) >= 80%; 5. Comorbid severe liver and kidney disease, or abnormal liver and kidney function tests (ALT or AST >= 1.5 times the upper limit of normal and SCR > the upper limit of normal); 6. Comorbid hypertension that remained uncontrolled after medical therapy, diabetes that remained poorly glycemic controlled after medical therapy; 7. Those with combined severe cardio cerebrovascular disease, autoimmune disease, malignancy, hematological disease, digestive system disease and other organic diseases; 8. Those with comorbid neurological or psychiatric disorders who are unable to cooperate or unwilling to cooperate, or who have suicidal tendencies; 9. Suspected or did have a history of alcohol, substance abuse, or a drug dependence predisposition; 10. A positive pregnancy test in a pregnant, lactating woman or in a reproductive age woman with a recent fertility planner; 11. Those with known or suspected history of allergy to the test drug and its excipients or serious adverse reactions; 12. Those treated with antimicrobials within 3 days prior to the trial; 13. 5 chemical agents regularly used in the treatment of chronic cholecystitis within half-life: such as ursodeoxycholic acid preparation (T1 / 2 = 5.8 days), trisulfde anisole (T1 / 2 = 16.2 h), pivinium bromide (T1 / 2 = 1.5 h), etc; 14. 1 regular use of Chinese herbal decoction or Chinese patent medicine for the treatment of chronic cholecystitis or with heat clearing and dampness effects within weeks; 15. Had participated in other clinical trials within 3 months before enrollment. 16. Other circumstances in which the investigator considered participation in this trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency of symptomatic response to right upper quadrant pain (flatulence or discomfort) at the end of 8 weeks of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in right upper quadrant pain (flatulence or discomfort) VAS scores and rates of change at the end of 8 weeks of medication;;Change values and rate of change from baseline in TCM symptom scores at the end of 8 weeks of medication use;;Efficacy of traditional Chinese medicine syndromes at the end of 8 weeks of medication use;Single item symptom disappearance rate in TCM syndromes at the end of 8 weeks of medication use;Color ultrasound of abdominal gallbladder at the end of 8 weeks of medication;Proportion of subjects using rescue medication and doses administered; | — |
Countries
China
Contacts
Public ContactFengbin Liu
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed