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IBS, Diarrhea PredominantPhase 3NCT07610434

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

A Phase 3 study testing Chang Ji'an capsule and Chang Ji'an capsule mimic in people with IBS, Diarrhea Predominant, run by Beijing Hospital of Traditional Chinese Medicine at 29 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
IBS, Diarrhea Predominant
What is being tested?
Chang Ji'an capsule and Chang Ji'an capsule mimic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
636 participants
Where
29 sitesChina
Study dates
31 May 2026to 31 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Have a colonoscopy result showing no obvious abnormalities (including diverticula or chronic inflammation) or colon polyps, based on colonoscopy results within 12 months prior at a tertiary hospital: 1.Colonoscopy results are normal with no organic changes; 2. Colonoscopy report shows minor abnormalities such as hemorrhoids or colonic polyps (diameter ≤5mm and number ≤3), which the investigator deems eligible for inclusion; 3. Previous colonoscopy reported colonic polyps with diameter >5mm or number >3, but after endoscopic treatment within 6 months prior to screening, remaining polyps are ≤5mm in diameter and ≤3 in number, deemed eligible by the investigator;
  • Agree to participate in this clinical trial and voluntarily sign the informed consent form.

Who cannot join

  • 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 non-IBS-D or other organic gastrointestinal lesions (excluding superficial gastritis, grade I erosive gastritis, or chronic atrophic gastritis found on endoscopy but deemed by the investigator to be eligible for inclusion (e.g., no mucosal erosion or bleeding observed endoscopically, and the patient has no upper abdominal fullness, upper abdominal pain, or acid reflux)), or other organic lesions that the investigator judges may cause abdominal pain, bloating, or discomfort;
  • 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;
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  • 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;
  • Individuals who have participated in another clinical trial within the past month;
  • Individuals known to have familial colorectal cancer syndrome;
  • Individuals who, in the opinion of the investigator, have other factors making them unsuitable for inclusion.

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

LuQing Zhao, Doctor contact

01087906580

zhaoluqing@bjzhongyi.com

29 sites in 1 country

China29 sites

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Dongcheng District, 100010

    LuQing Zhao, Doctor, 01087906580, zhaoluqing@bjzhongyi.com

  • West China Hospital, Sichuan University

    Chengdu

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou

  • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

    Guizhou

  • Haozhou People's Hospital

    Haozhou

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    Hebei

  • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Heilongjiang

  • Hubei Provincial Hospital of Traditional Chinese Medicine

    Hubei

  • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng

  • Luoyang First People's Hospital

    Luoyang

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai

  • The Affiliated Hospital of Shaanxi University of Chinese Medicine

    Shanxi

  • Shaoyang Central Hospital

    Shaoyang

  • Shiyan People's Hospital

    Shiyan

  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin

  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin

  • Wenzhou Traditional Chinese Medicine Hospital

    Wenzhou

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

    Wuhan

  • Wuxi Traditional Chinese Medicine Hospital

    Wuxi

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xi'an Central Hospital

    Xi'an

  • Xingtai People's Hospital

    Xingtai

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

    Yueyang

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Zhejiang

  • Zhengzhou First People's Hospital

    Zhengzhou

  • Zhujiang Hospital, Southern Medical University

    Zhujiang

Other trials in China

About this study

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)

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.

Being tested
Chang Ji'an capsule, Chang Ji'an capsule mimic
Medical subject headings
Ichthyosis Bullosa of Siemens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chang Ji'an capsuleDrug

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

  • Chang Ji'an capsule mimicDrug

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

Study groups in NCT07610434
Study groupRoleWhat they receive
Chang Ji'an capsule groupExperimentalChang Ji'an Capsules, 4 capsules each time, 3 times a day, orally
Receives: Drug: Chang Ji'an capsule
Placebo groupPlacebo comparatorChang Ji'an Capsules mimic, 4 capsules per dose, 3 times a day, orally
Receives: Drug: Chang Ji'an capsule mimic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Evaluation will be performed at Day 56.

Secondary outcomes (14)

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

    Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.

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

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

    Proportion of subjects who met the following criteria for at least 50% of the period from randomization to week endpoint: 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.

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

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

    Defined as the proportion of subjects who meet the following criteria during at least 50% of the treatment period from randomization to the week endpoint: 1.Intensity of abdominal pain, abdominal distension and abdominal discomfort: a decrease in the weekly average of worst abdominal pain, abdominal distension and abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline; 2.Stool form: 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.

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

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

    Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal distention in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.

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

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

    Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.

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

  6. Changes in the number of days with diarrhea in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment

    Among patients with unchanged or improved intensity of abdominal pain, abdominal distension and abdominal discomfort, the change from baseline in the number of days with Bristol Stool Form Scale type 6 or 7 at least once during the week.

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

  7. Changes in the average number of diarrhea episodes in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment

    Defined as the change from baseline in the weekly frequency of Bristol Stool Form Scale Type 6 or 7 stools divided by 7 days, among patients whose intensity of abdominal pain, abdominal distension, and abdominal discomfort remained unchanged or improved.

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

  8. Changes in Urgency Numeric Rating Scale(Likert 5 point scale, score range:0-4, Lower-is-Better endpoint) compared to baseline at the end of weeks 2, 4, 6, and 8, and in the past 2 weeks

    Assessed based on the change in defecation urgency score.

    Measured: Evaluation will be performed at baseline and D14, D28, D42, D56.

  9. Changes from baseline in IBS Symptom Severity Score (IBS-SSS, score range:0-500, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.

    Assessed by the changes in scores of the IBS-SSS scales.

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

  10. Changes from baseline in Quality of Life scale score (IBS-QOL, score range:0-136, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.

    Assessed by the changes in scores of the IBS-QOL scales.

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

  11. Changes from baseline in Traditional Chinese Medicine syndrome score at the end of treatment weeks 2, 4, 6 and 8.

    Assessed by the changes in Traditional Chinese Medicine (TCM) syndrome scores.

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

  12. Proportion of subjects with sustained remission and no worsening of diarrhea severity at Week 4 and Week 8 during the follow-up period.

    Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.

    Measured: Evaluations will be performed at baseline, 4 and 8 weeks of the follow-up period after the end of treatment.

  13. Proportion of subjects without diarrhea associated with diarrhea-predominant irritable bowel syndrome at follow-up Week 4 and Week 8.

    Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.

    Measured: Evaluations will be performed at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56 after treatment completion.

  14. Usage of rescue medication

    Statistical analysis will be performed based on the consumption of rescue medication throughout the entire trial period.

    Measured: Evaluations shall be conducted at Week 8 of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start31 May 2026 (estimated)
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
636 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610434
Sponsor's protocol ID
FA-CJA-III-2510
Status last verified
May 2026
First submitted
17 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26789872

  • 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.

    PubMed 23583433

  • 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.

    PubMed 35114338

  • 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.

    PubMed 41713703

  • 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.

    PubMed 21208106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chang Ji'an capsule and Chang Ji'an capsule mimic in people with IBS, Diarrhea Predominant, run by Beijing Hospital of Traditional Chinese Medicine at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact LuQing Zhao, Doctor (01087906580, zhaoluqing@bjzhongyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment (time frame: Evaluation will be performed at Day 56.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07610434, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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