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

Beijing Youan Hospital, Capital Medical University0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•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.

•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.

发起方

Beijing Youan Hospital, Capital Medical University