A Randomized Controlled Clinical Study of Ba-Bao-Dan Capsule in the Treatment of Gallbladder Polyps Below 10mm

Phase 4

Not yet recruiting

• Conditions: Gallbladder polyps

• Registration Number: ITMCTR2000003407
• Lead Sponsor: Beijing Youan Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age: 18-65 years old (when signing informed consent);
2. Gender: male or female;
3.Those who have polypoid lesions of gallbladder by color Doppler ultrasound examination; the size of polyps is 0-10 mm, single or multiple polyps;
4. There is no restriction on whether the patient has cholecystitis;
5. The patient may be accompanied by some non-specific symptoms: such as radiation pain in the right shoulder and hidden pain in the right upper abdomen, which may or may not be accompanied by bloating, nausea, and anorexia;
6. The TCM syndrome type should be in accordance with the Consensus of Cholecystitis Chinese Medicine Experts (2017)[20] The clinical manifestations of the syndrome of liver, gallbladder, dampness and heat are as follows:
The main symptoms: (1) Flank pain; (2) Morning Mouth bitter; (3) Dry mouth to drink.
Secondary Symptoms: (1) Yellow body; (2) Weight and sleepiness; (3) Abdominal distension; (4) Dry throat; (5) Short yellow urine; (6) Uncomfortable stool or secretion.
Tongue veins: (1) Red tongue, yellow fur or thick greasy; (2) Pulse string slippage.
Syndrome diagnosis: it has the main symptom (1) + another main symptom and two sub-symptoms, which can be diagnosed by referring to the tongue and veins.
7. Unwilling to undergo gallbladder polypectomy and agreed to participate in this trial;
8. Sign written informed consent.

Exclusion Criteria

1. Before entering the group, it is known that polyps increase in the short term;
2. Combined with gallstones or primary sclerosing cholangitis (PSC);
3. Those who are known or suspected to be allergic to Babaodan capsules, have a history of allergy to biological agents, have allergies or are in an allergic state;
4. Those who cannot take drugs orally;
5. Those who are participating in other clinical trials;
6. HIV infection or the existence of AIDS-related diseases;
7. Combined with liver cancer, hepatic encephalopathy, gastrointestinal bleeding, acute and chronic liver failure, hepatorenal syndrome, hepatopulmonary syndrome, primary nephropathy, and severe cardiovascular and cerebrovascular, lung, renal, endocrine and hematopoietic systems Primary disease;
8. Lactating and pregnant women;
9. Performed gallbladder related surgery within 3 months;
10. There is a history of mental system disease or abnormal behavior, etc., who cannot cooperate with this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main efficacy evaluation indicators: polyp diameter, number of polyps, thickness of gallbladder wall;

Secondary Outcome Measures

Name	Time	Method
Safety indicators: electrocardiogram, liver and kidney function, adverse events, etc;Secondary efficacy evaluation indicators: TCM syndrome efficacy, single symptom efficacy, clinical symptoms and signs;