Herbal tablet aims to calm IBS-Related diarrhea and pain
NCT ID NCT05687435
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
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Jan 2023
- Finished
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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
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18 to 65 years
- Sex
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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 Hide 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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Other studies related to the condition(s) this trial covers.