Herbal tablet aims to calm IBS-Related diarrhea and pain

NCT ID NCT05687435

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether the Chinese herbal tablet Changyanning can reduce diarrhea and abdominal pain in people with diarrhea-predominant irritable bowel syndrome (IBS-D). About 240 adults aged 18 to 65 with moderate to severe symptoms will receive either the herbal tablet or a placebo for several weeks. The study measures how many people have at least a 30% drop in pain and fewer days with loose stools.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a Chinese herbal tablet called Changyanning, made from Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens, and maple leaves
What this could lead to
If it works, this could offer a new herbal treatment option for managing diarrhea and abdominal pain in IBS-D.
What could go wrong
This is a Phase 4 trial with 240 participants, so results may not apply to everyone. Herbal products can vary in quality and may cause side effects or interact with other medications.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

240 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2024

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 IBS-D Rome IV diagnostic criteria; 2. Age between 18 and 65 years old (including boundary value), regardless of gender; 3. IBS symptom severity scale (IBS-SSS) scores \> 175 points; 4. The weekly average score of abdominal pain in screening period is ≥ 3 points (The most severe abdominal pain in the past 24 hours every day, the pain score was 11 grades (0-10), NRS-11; Also the number of days of the stool character classification (Bristol stool scale) is type 6 or 7 ≥ 2 in a week; 5. Patients who voluntarily accept the program's plan of the project and signs the informed consent form. Exclusion Criteria: 1. Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors; 2. Patients are affected by factors such as intellectual disorder, mental disorder and language; 3. Patients with gastrointestinal organic diseases or with malignant tumors, such as pancreatitis, intestinal adenoma (excluding polypectomy for more than half a month), intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease, intestinal tuberculosis, etc; 4. Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics; 5. Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases; 6. Allergic constitution or allergic to the components of the studied drug; 7. Pregnant or lactating women, and women with recent fertility plans; 8. Previous abdominal or pelvic surgery, such as cholecystectomy; 9. Patients with positive fecal occult blood; 10. During the screening period, drugs that affect gastrointestinal motility and function cannot be stopped, including parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta, etc; Opioid preparations, etc; 11. Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study; 12. IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study; 13. Those who regularly drink alcohol within 6 months before screening, i.e., drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol); 14. Those who have participated in or are currently participating in other clinical trials within 1 month before screening; 15. The researcher believes that there are patients who are not suitable for inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mei Han,Associate professor,Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100029, China

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