ITMCTR2026001757招募中3 期
Placebo-controlled evaluation of Chaihuo Li Dan Capsules for the treatment of chronic cholelithiasis (Liver-Gallbladder Damp-Heat and Stomach Qi Disharmony Pattern) in a randomized, double-blind, multicenter Phase IIIb clinical trial
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital0 个研究点开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Meets the diagnostic criteria for chronic calculous cholecystitis in Western medicine;
- •(2) Meets the diagnostic criteria for Liver and Gallbladder Damp-Heat and Stomach Qi Disharmony in Traditional Chinese Medicine;
- •(3) Stable condition at screening, no need for surgical treatment, and willing to accept drug therapy;
- •(4) Right upper quadrant pain (dull pain or discomfort) VAS average score during the run-in period is between 40mm-80mm (inclusive of both ends);
- •(5) Age between 18 and 65 years (inclusive), gender;
- •(6) Agree to participate in this clinical trial, sign the informed consent form, and be able to voluntarily follow dietary adjustment recommendations.
排除标准
- •(1) Those confirmed to have non-stone cholecystitis, common bile duct stones, impacted stones in the neck of the gallbladder, gallbladder stones filling the entire gallbladder, acute obstructive suppurative cholangitis, acute suppurative cholecystitis, acute gangrenous cholecystitis, acute obstructive cholecystitis, gallbladder polyps > 1 cm, single gallbladder stones with a maximum diameter > 2.5 cm, gallbladder tumors, gallbladder perforation complicated with diffuse peritonitis or combined with chronic pancreatitis;
- •(2) Those meeting the surgical indications for cholecystitis or planning to undergo surgery within 3 months;
- •(3) Those with other digestive system diseases (such as active peptic ulcers, acute pancreatitis, acute appendicitis, etc.), or with a history of gastric and duodenal ulcers, chronic gastritis, reflux esophagitis, chronic pancreatitis, etc., and still having obvious symptoms at the time of screening that are difficult to distinguish from the symptoms and signs of this disease, which may affect the evaluation of therapeutic effect;
- •(4) Those with serum amylase levels more than 1.5 times the upper limit of normal;
- •(5) Those with clinical symptoms of kidney and ureteral stones;
- •(6) Those meeting all three of the following conditions: body temperature (axillary temperature) = 37.5°C, white blood cells (WBC) > 11.0×109/L, and neutrophil percentage (NE%) = 80%;
- •(7) Those with severe fatty liver, serious liver and kidney diseases, or abnormal liver and kidney function tests (ALT or AST = 1.5 times the upper limit of normal, Scr > upper limit of normal);
- •(8) Those with uncontrolled hypertension despite drug treatment, or with poorly controlled diabetes despite drug treatment;
- •(9) Those with severe cardiovascular and cerebrovascular diseases, autoimmune diseases, malignant tumors, hematological diseases, or other organic diseases;
- •(10) Those with neurological or mental disorders that prevent cooperation or willingness to cooperate, or with suicidal tendencies;
- •(11) Those suspected or confirmed to have a history of alcohol or drug abuse, or with a tendency towards drug dependence;
- •(12) Pregnant or lactating women, or women of childbearing age with a positive pregnancy test, or those with a plan to conceive within the next six months;
- •(13) Those known or suspected to have an allergy or severe adverse reaction to the test drug or its excipients;
- •(14) Those who have received antibiotic treatment within 3 days before the trial;
- •(15) Those who have regularly used chemical drugs for chronic cholecystitis within 5 half-lives before the trial: such as ursodeoxycholic acid preparations (T1/2 = 5.8 days), artemether (T1/2 = 16.2 hours), pinaverium bromide (T1/2 = 1.5 hours), etc.;
- •(16) Those who have regularly used traditional Chinese medicine decoctions or patent medicines for chronic cholecystitis or with heat-clearing and dampness-removing effects within one week before the trial;
- •(17) Those who have participated in other clinical trials within 3 months before enrollment;
- •(18) Those considered by the investigator to be unsuitable for participation in this trial for other reasons.
研究者
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