Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)
NCT ID: NCT06753890
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
520 participants
INTERVENTIONAL
2024-12-30
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Changkang granules
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang granules
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang granules Placebo
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang Granules placebo
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Interventions
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Changkang granules
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang Granules placebo
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Eligibility Criteria
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Inclusion Criteria
2. Meet the Western medical diagnostic criteria for Irritable Bowel Syndrome with Predominant Diarrhea (Rome IV);
3. Meet the Traditional Chinese Medicine diagnostic criteria for Liver qi affecting the spleen pattern
4. Have a weekly average NRS score for abdominal pain ≥3.0 during the Run-In Period period, and have at least 2 days per week with stool form of type 6 or 7 (Bristol Stool Scale) during the Run-in period;
5. Have an IBS-SSS score \>175 at baseline;
6. Have completed a colonoscopy within the past 12 months prior to the Run-in period, and meet one of the following conditions: ① Normal colonoscopy results with no organic changes; ② Abnormal colonoscopy report, such as hemorrhoids, polyps (diameter ≤5mm and number ≤3), etc., which the investigator determines can be included; ③ Previous colonoscopy report indicating polyps \>5mm in diameter or \>3 in number, which after endoscopic treatment 6 months ago, residual polyps are ≤5mm in diameter and ≤3 in number, and the investigator determines can be included;
7. Voluntarily sign the informed consent form, and from the time of signing the informed consent form until the end of the last visit of the trial, the participant voluntarily accepts health education and maintains their usual diet and lifestyle, such as not changing dietary structure or exercise patterns.
Exclusion Criteria
1. Subjects who have less than 3 spontaneous bowel movements per week during the run-in period; or at least 2 days per week during the run-in period with stool consistency classified as type 1 or 2 on the Bristol Stool Scale;
2. Patients with a history of severe mental or psychological disorders, or those scoring ≥63 on the Self-Rating Depression Scale (SDS), or ≥60 on the Self-Rating Anxiety Scale (SAS) during the screening period;
3. Patients with a confirmed history of organic gastrointestinal diseases, including both gastrointestinal and non-gastrointestinal digestive system diseases, such as chronic superficial gastritis with erosions or bleeding of grade II or higher, chronic atrophic gastritis, peptic ulcers, inflammatory bowel disease, intestinal tuberculosis, intestinal ulcers, intestinal obstruction, intestinal adhesions, eosinophilic gastroenteritis, cholelithiasis with recurrent cholecystitis (patients with gallstones or gallbladder polyps ≤0.5 cm in diameter and no significant symptoms may be exempted from exclusion upon investigator's judgment), tuberculous peritonitis, liver cirrhosis, and digestive system tumors, etc.;
4. Patients diagnosed with other diseases that affect the evaluation of abdominal pain and diarrhea, such as diarrhea caused by lactose intolerance, diarrhea after cholecystectomy, abdominal pain due to endometriosis, abdominal pain caused by hepatic and biliary stones or cholecystitis, abdominal pain due to chronic pancreatitis, etc.;
5. Patients with a history of systemic diseases affecting gastrointestinal function, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (such as allergic colitis, allergic purpura, Behcet's syndrome, systemic lupus erythematosus), etc.;
6. Patients with a history of major abdominal surgery involving the gastrointestinal tract, liver, gallbladder, spleen, or pancreas (subjects who have undergone appendectomy or cesarean section without impact on gut function may be exempted from exclusion upon investigator's judgment);
7. Patients with unexplained recurrent positive fecal occult blood, unintentional weight loss, anemia, fever, or jaundice prior to screening;
8. Abnormal liver function at baseline (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function at baseline (Cr \>upper limit of normal);
9. Patients with a history of severe diseases in the respiratory, cardiovascular, cerebral, hepatic, renal, endocrine, immune, hematopoietic systems, as well as tumors and neurological diseases, deemed unsuitable for participation in this trial by the investigator;
10. Patients who have used prokinetic agents, anticholinergic drugs, calcium channel blockers (excluding antihypertensive drugs), 5-HT3 receptor antagonists, antidiarrheals, antidepressants, anxiolytics, probiotics, analgesics, laxatives, etc., within 4 weeks before randomization;
11. Patients who took rescue medication (piroxicam) during the run-in period;
12. Pregnant or breastfeeding women, or those planning to conceive within 1 month after enrollment until the end of the trial;
13. Patients suspected or known to be allergic to the investigational drug, rescue medication, or its components;
14. Patients suspected or known to have a history of alcohol or drug abuse;
15. Patients who participated in another interventional clinical trial and took investigational drugs within 1 month before screening;
16. Patients whom the investigator deems unsuitable for clinical trial participation for any other reason.
18 Years
65 Years
ALL
No
Sponsors
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Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Baoding First Traditional Chinese Medicine Hospital
Baoding, , China
No. 5, Beixiange Street, Xuanwu District, Beijing
Beijing, , China
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, , China
Changde Second People's Hospital
Chengde, , China
Chengdu Shuangliu District First People's Hospital
Chengdu, , China
Sichuan University West China Hospital
Chengdu, , China
Guangzhou First People's Hospital
Guangzhou, , China
Zhejiang Provincial Tongde Hospital
Hangzhou, , China
Zhejiang Xinhua Hospital
Hangzhou, , China
Kaifeng City Traditional Chinese Medicine Hospital
Kaifeng, , China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, , China
Luoyang Central Hospital
Luoyang, , China
Luoyang First People's Hospital
Luoyang, , China
Jiangxi University of Traditional Chinese Medicine Affiliated Hospital
Nanchang, , China
Nanjing Traditional Chinese Medicine Hospital
Nanjing, , China
Guangxi Traditional Chinese Medicine University Affiliated Rui Kang Hospital
Nanning, , China
Sanmenxia Central Hospital
Sanmenxia, , China
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Shanghai, , China
Liaoning University of Traditional Chinese Medicine Third Affiliated Hospital
Shenyang, , China
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, , China
Hebei Provincial People's Hospital
Shijiazhuang, , China
Tianjin University of Traditional Chinese Medicine Second Affiliated Hospital
Tianjin, , China
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, , China
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou, , China
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan, , China
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, , China
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi'an, , China
Shanxi University of Chinese Medicine Affiliated Hospital
Xianyang, , China
The Second Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, , China
Yangquan Coal Industry (Group) Co., Ltd. General Hospital
Yangquan, , China
Countries
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Central Contacts
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Facility Contacts
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Lipu Wang
Role: primary
Zhen Liu
Role: primary
Juan ni Zeng
Role: primary
Xianyi Wang
Role: primary
Mei Hua Wan
Role: primary
Wenfu Tang
Role: primary
Baoying Fei
Role: primary
Jihong Zhong
Role: primary
Qinghua Zhao
Role: primary
Xudong Tian
Role: primary
Hongwei Chen
Role: primary
Hongling Liu
Role: primary
Ling He
Role: primary
Qin Yang
Role: primary
Tao Zhang
Role: primary
Xuemin Zhai
Role: primary
Jiang Lin
Role: primary
Yue Dong Liu
Role: primary
Qian Yang
Role: primary
Gaifang Liu
Role: primary
Hui Zhen Li
Role: primary
Dingyuan Hu
Role: primary
Yaoming Zeng
Role: primary
Heng Fan
Role: primary
Yunlian Hu
Role: primary
tao Yu
Role: primary
Jiehong Wang
Role: primary
Fengli Zhang
Role: primary
Jianming Wang
Role: primary
Other Identifiers
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TSL-TCM-CKKL-III
Identifier Type: -
Identifier Source: org_study_id