UnknownPhase 2/3

Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

240 participantsStarted 2023-01-30

Plain-language summary

The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are: 1. Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients? 2. Is Changchangning Tablet safe for the treatment of IBS-D?

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Meet IBS-D Rome IV diagnostic criteria;
. Age between 18 and 65 years old (including boundary value), regardless of gender;
. IBS symptom severity scale (IBS-SSS) scores \> 175 points;
. 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;
. Patients who voluntarily accept the program's plan of the project and signs the informed consent form.

Exclusion criteria

. Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;
. Patients are affected by factors such as intellectual disorder, mental disorder and language;
. 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;
. Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weekly response rate of abdominal pain and diarrhea

Timeframe: 8 weeks (after treatment)

Trial details

NCT IDNCT05687435

SponsorMei Han

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-31

Contact for this trial

Mei Han, Dr

+8613401131731 hanmeizoujin@163.com

View on ClinicalTrials.gov More Diarrhea-Predominant Irritable Bowel Syndrome trials