Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)

NCT06753890 | Not Yet Recruiting Phase 3

• 1 other identifier: TSL-TCM-CKKL-III
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 30

Brief Summary

This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)

Conditions

Diarrhea-predominant Irritable Boewl Syndrome

Outcome Measures

Primary Outcomes (1)

• abdominal pain response rate

  The primary efficacy endpoint is the weekly response rate to abdominal pain after 4 weeks of treatment.

  4 week

Secondary Outcomes (11)

• The change in the average weekly score of abdominal pain compared to baseline

  Baseline, Week 1，Week 2，week3 and week4

• Weekly Composite Response Rate

  4 week

• The change in total IBS-SSS score and each individual item score from baseline

  4 week

• The change in total IBS-SSS score and each individual item score from baseline

  up to 10 week

• Weekly stool consistency response rate

  4 week

Study Arms (2)

Changkang granules

EXPERIMENTAL

7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.

Drug: Changkang granules

Changkang granules Placebo

PLACEBO COMPARATOR

7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.

Drug: Changkang Granules placebo

Interventions

Changkang granules DRUG

7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.

Changkang granules

Changkang Granules placebo DRUG

7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.

Changkang granules Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years (inclusive), regardless of gender;
• Meet the Western medical diagnostic criteria for Irritable Bowel Syndrome with Predominant Diarrhea (Rome IV);
• Meet the Traditional Chinese Medicine diagnostic criteria for Liver qi affecting the spleen pattern
• 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;
• Have an IBS-SSS score \>175 at baseline;
• 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;
• 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.

You may not qualify if:

• Subjects with any of the following conditions are not eligible for enrollment in this study:
• 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;
• 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;
• 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.;
• 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.;
• Patients with unexplained recurrent positive fecal occult blood, unintentional weight loss, anemia, fever, or jaundice prior to screening;
• 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);
• 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;
• 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;
• Patients who took rescue medication (piroxicam) during the run-in period;
• Pregnant or breastfeeding women, or those planning to conceive within 1 month after enrollment until the end of the trial;
• Patients suspected or known to be allergic to the investigational drug, rescue medication, or its components;
• Patients suspected or known to have a history of alcohol or drug abuse;
• Patients who participated in another interventional clinical trial and took investigational drugs within 1 month before screening;
• Patients whom the investigator deems unsuitable for clinical trial participation for any other reason.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (30)

Baoding First Traditional Chinese Medicine Hospital

Baoding, China

Location

No. 5, Beixiange Street, Xuanwu District, Beijing

Beijing, China

Location

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, China

Location

Changde Second People's Hospital

Chengde, China

Location

Chengdu Shuangliu District First People's Hospital

Chengdu, China

Location

Sichuan University West China Hospital

Chengdu, China

Location

Guangzhou First People's Hospital

Guangzhou, China

Location

Zhejiang Provincial Tongde Hospital

Hangzhou, China

Location

Zhejiang Xinhua Hospital

Hangzhou, China

Location

Kaifeng City Traditional Chinese Medicine Hospital

Kaifeng, China

Location

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, China

Location

Luoyang Central Hospital

Luoyang, China

Location

Luoyang First People's Hospital

Luoyang, China

Location

Jiangxi University of Traditional Chinese Medicine Affiliated Hospital

Nanchang, China

Location

Nanjing Traditional Chinese Medicine Hospital

Nanjing, China

Location

Guangxi Traditional Chinese Medicine University Affiliated Rui Kang Hospital

Nanning, China

Location

Sanmenxia Central Hospital

Sanmenxia, China

Location

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

Shanghai, China

Location

Liaoning University of Traditional Chinese Medicine Third Affiliated Hospital

Shenyang, China

Location

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, China

Location

Tianjin University of Traditional Chinese Medicine Second Affiliated Hospital

Tianjin, China

Location

Wenzhou Medical University Affiliated Second Hospital

Wenzhou, China

Location

Wenzhou Traditional Chinese Medicine Hospital

Wenzhou, China

Location

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

Wuhan, China

Location

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, China

Location

Shanxi Provincial Hospital of Traditional Chinese Medicine

Xi'an, China

Location

Shanxi University of Chinese Medicine Affiliated Hospital

Xianyang, China

Location

The Second Affiliated Hospital of Shanxi University of Chinese Medicine

Xianyang, China

Location

Yangquan Coal Industry (Group) Co., Ltd. General Hospital

Yangquan, China

Location

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui2@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 31, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

CN (30)