Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)

NCT07610434 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: FA-CJA-III-2510
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 29

Brief Summary

This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trial. Its purpose is to evaluate the efficacy and safety of Changji'an Capsules in subjects with diarrhea-predominant irritable bowel syndrome (liver-qi invading spleen syndrome) after 8 weeks of treatment.

Conditions

IBS, Diarrhea Predominant

Outcome Measures

Primary Outcomes (1)

• Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment

  Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of Week 8 of treatment: patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.

  Evaluation will be performed at Day 56.

Secondary Outcomes (14)

• The abdominal pain response rate at the end of treatment weeks 2, 4, 6 and 8

  Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.

• The response rate of diarrhea (stool form) at the end of treatment weeks 2, 4 and 6

  Evaluation will be performed at baseline and Day 14, Day 28, Day 42.

• Treatment response rate at the end of treatment weeks 2, 4, 6 and 8

  Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.

• Distention response rate at the end of treatment weeks 2, 4, 6 and 8

  Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.

• Response rate of abdominal discomfort at the end of 2, 4, 6, and 8 weeks of treatment

  Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.

Study Arms (2)

Chang Ji'an capsule group

EXPERIMENTAL

Chang Ji'an Capsules, 4 capsules each time, 3 times a day, orally

Drug: Chang Ji'an capsule

Placebo group

PLACEBO COMPARATOR

Chang Ji'an Capsules mimic, 4 capsules per dose, 3 times a day, orally

Drug: Chang Ji'an capsule mimic

Interventions

Chang Ji'an capsule DRUG

The prescription consists of 13 medicinal ingredients including Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae (processed), and Radix Astragali.

Chang Ji'an capsule group

Chang Ji'an capsule mimic DRUG

Mock capsules with "no pharmaceutically active ingredients", identical to the Chang Ji'an capsule in color, odor and appearance.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
• Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen;
• Aged ≥18 and ≤65 years, regardless of gender;
• Record daily the most severe abdominal pain, bloating, and abdominal discomfort NRS scores for the last week of the run-in period. At least one of these three items must meet the weekly average NRS score criterion (the weekly average of abdominal pain NRS is calculated as: total weekly score of abdominal pain NRS on days with Bristol Stool Form Scale type 6 or 7 stools / actual number of days with Bristol type 6 or 7 stools in that week; the average values for the other two items are calculated similarly) ≥3 points (11-point Numerical Rating Scale, NRS-11); meanwhile, for stool form, during the last week of the run-in period, there must be at least 2 days in which each day has at least one bowel movement of Bristol type 6 or 7;
• Self-Rating Anxiety Scale (SAS) \<60 points and Self-Rating Depression Scale (SDS) \<63 points;
• Agree to participate in this clinical trial and voluntarily sign the informed consent form.

You may not qualify if:

• Individuals with fewer than 3 spontaneous bowel movements per week during the induction period;
• Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period;
• Individuals confirmed to have infectious diarrhea, inflammatory bowel disease, parasitic infection, positive fecal occult blood tests and considered to have gastrointestinal bleeding (excluding hemorrhoids), colorectal tumors, malabsorption syndrome, lactose intolerance (based on medical history), and diarrhea caused by systemic diseases;
• Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening;
• Individuals with diabetes, hyperthyroidism, or serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, or other serious diseases affecting survival (e.g., tumors), abnormal liver and kidney function (AST, ALT \> 1.5 times the upper limit of normal reference range, Scr above the upper limit of normal reference range), and clinically significant ECG abnormalities;
• Individuals with other mental disorders (excluding mild anxiety or depression);
• Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal);
• Individuals who, within 2 weeks prior to screening, are using or need to continue using medications that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal drugs, antacids, prokinetic drugs, antidepressants (fluoxetine for at least 28 days), anti-anxiety drugs, intestinal microbiota regulators, traditional Chinese medicine decoctions, etc.);
• Individuals allergic to 3 or more medications or foods, or known allergies to Xiangjie Capsules and its components, as well as emergency medication Pivabromium tablets;
• Individuals who took emergency medication (Pivabromium tablets) during the last week of the induction period;
• Individuals who took prohibited medications during the induction period;
• Individuals suspected of or confirmed with a history of alcohol or drug abuse;
• Pregnant women, breastfeeding women, or women of childbearing age planning to conceive; or female participants of childbearing potential and male participants (whose partners are women of childbearing potential) who do not agree to voluntarily use effective contraception from screening to 3 months after the last dose;
• Individuals with cognitive impairment unable to provide fully informed consent;
• Individuals positive for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or syphilis treponemal antibody;

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (29)

Beijing Hospital of Traditional Chinese Medicine

Beijing, Dongcheng District, 100010, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, China

Location

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guizhou, China

Location

Haozhou People's Hospital

Haozhou, China

Location

Hebei Provincial Hospital of Traditional Chinese Medicine

Hebei, China

Location

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Heilongjiang, China

Location

Hubei Provincial Hospital of Traditional Chinese Medicine

Hubei, China

Location

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, China

Location

Kaifeng Hospital of Traditional Chinese Medicine

Kaifeng, China

Location

Luoyang First People's Hospital

Luoyang, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

Location

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

The Affiliated Hospital of Shaanxi University of Chinese Medicine

Shanxi, China

Location

Shaoyang Central Hospital

Shaoyang, China

Location

Shiyan People's Hospital

Shiyan, China

Location

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Wenzhou Traditional Chinese Medicine Hospital

Wenzhou, China

Location

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

Wuhan, China

Location

Wuxi Traditional Chinese Medicine Hospital

Wuxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Xi'an Central Hospital

Xi'an, China

Location

Xingtai People's Hospital

Xingtai, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Yueyang, China

Location

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Zhejiang, China

Location

Zhengzhou First People's Hospital

Zhengzhou, China

Location

Zhujiang Hospital, Southern Medical University

Zhujiang, China

Location

Related Publications (5)

• Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.

  PMID: 26789872 BACKGROUND

• Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.

  PMID: 23583433 BACKGROUND

• Wang Z, Xu M, Shi Z, Bao C, Liu H, Zhou C, Yan Y, Wang C, Li G, Zhang W, Gao A, Wu H. Mild moxibustion for Irritable Bowel Syndrome with Diarrhea (IBS-D): A randomized controlled trial. J Ethnopharmacol. 2022 May 10;289:115064. doi: 10.1016/j.jep.2022.115064. Epub 2022 Jan 31.

  PMID: 35114338 BACKGROUND

• Corsetti M, Shin A, Lacy BE, Cash BD, Simren M, Schmulson MJ, Hou X, Lembo A. Bowel Disorders. Gastroenterology. 2026 May;170(6):1261-1282. doi: 10.1053/j.gastro.2026.02.003. Epub 2026 Feb 17.

  PMID: 41713703 BACKGROUND

• Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.

  PMID: 21208106 BACKGROUND

MeSH Terms

Conditions

Ichthyosis Bullosa of Siemens

Interventions

tebufenozide

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

LuQing Zhao, Doctor

CONTACT

01087906580; zhaoluqing@bjzhongyi.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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, professor and doctoral supervisor

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 28, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)