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Herbal capsule could offer relief for chronic diarrhea sufferers

NCT ID NCT07610434

Symptom relief Sponsor: Beijing Hospital of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether Changji'an capsules, a traditional Chinese medicine, can reduce diarrhea and stomach pain in people with irritable bowel syndrome (IBS) where diarrhea is the main symptom. About 636 adults aged 18 to 65 will take the capsule or a placebo for 8 weeks. The goal is to see if the capsule improves stool consistency and pain without serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 636 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome; 2. Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen; 3. Aged ≥18 and ≤65 years, regardless of gender; 4. 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; 5. Self-Rating Anxiety Scale (SAS) \<60 points and Self-Rating Depression Scale (SDS) \<63 points; 6. 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; 7. Agree to participate in this clinical trial and voluntarily sign the informed consent form. Exclusion Criteria: 1. Individuals with fewer than 3 spontaneous bowel movements per week during the induction period; 2. Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period; 3. 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; 4. Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening; 5. 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; 6. 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; 7. Individuals with other mental disorders (excluding mild anxiety or depression); 8. Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal); 9. 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.); 10. 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; 11. Individuals who took emergency medication (Pivabromium tablets) during the last week of the induction period; 12. Individuals who took prohibited medications during the induction period; 13. Individuals suspected of or confirmed with a history of alcohol or drug abuse; 14. 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; 15. Individuals with cognitive impairment unable to provide fully informed consent; 16. Individuals positive for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or syphilis treponemal antibody; 17. Individuals who have participated in another clinical trial within the past month; 18. Individuals known to have familial colorectal cancer syndrome; 19. Individuals who, in the opinion of the investigator, have other factors making them unsuitable for inclusion.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome superficial epidermolytic ichthyosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBS, diarrhea predominant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Dongcheng District, 100010, China

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, China

  • Haozhou People's Hospital

    Haozhou, China

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    Hebei, China

  • Hubei Provincial Hospital of Traditional Chinese Medicine

    Hubei, China

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing, China

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng, China

  • Luoyang First People's Hospital

    Luoyang, China

  • Shaoyang Central Hospital

    Shaoyang, China

  • Shiyan People's Hospital

    Shiyan, China

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, China

  • The Affiliated Hospital of Shaanxi University of Chinese Medicine

    Shanxi, China

  • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, China

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

    Guizhou, China

  • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Heilongjiang, China

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

    Tianjin, China

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

    Tianjin, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

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

    Wuhan, China

  • Wenzhou Traditional Chinese Medicine Hospital

    Wenzhou, China

  • West China Hospital, Sichuan University

    Chengdu, China

  • Wuxi Traditional Chinese Medicine Hospital

    Wuxi, China

  • Xi'an Central Hospital

    Xi'an, China

  • Xingtai People's Hospital

    Xingtai, China

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

    Yueyang, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Zhejiang, China

  • Zhengzhou First People's Hospital

    Zhengzhou, China

  • Zhujiang Hospital, Southern Medical University

    Zhujiang, China

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