Diarrhea-Predominant Irritable Bowel SyndromePhase 4NCT05687435
Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 4 study testing Changyanning tablet in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by Mei Han at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea-Predominant Irritable Bowel Syndrome
- What is being tested?
- Changyanning tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 29 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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;
- Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;
- Allergic constitution or allergic to the components of the studied drug;
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- Pregnant or lactating women, and women with recent fertility plans;
- Previous abdominal or pelvic surgery, such as cholecystectomy;
- Patients with positive fecal occult blood;
- 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;
- Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;
- IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;
- 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);
- Those who have participated in or are currently participating in other clinical trials within 1 month before screening;
- The researcher believes that there are patients who are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Mei Han，Associate professor，Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029
About this study
Official title: Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
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:
- Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients?
- Is Changchangning Tablet safe for the treatment of IBS-D?
- Being tested
- Changyanning tablet, Changyanning tablet placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changyanning tabletDrug
Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons.
If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.
Changyanning tablet placeboOther
Changyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients.
If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.
| Study group | Role | What they receive |
|---|---|---|
| Changyanning group | Experimental | Changyanning tablet: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. Receives: Drug: Changyanning tablet |
| Placebo group | Placebo comparator | Changyanning tablet placebo: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. Receives: Other: Changyanning tablet placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly response rate of abdominal pain and diarrhea
The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).
② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.
The response rate=(the number of the responders/the sample size of the group) x100%.
Measured: 8 weeks (after treatment)
Secondary outcomes (6)
Weekly response rate of abdominal pain and diarrhea
The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).
② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.
The response rate=(the number of the responders/the sample size of the group) x100%.
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Weekly response rate of diarrhea
The responder is defined when the following two points are met simultaneously： ①Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.
②Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is remained unchanged or improved from baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).
The response rate=(the number of the responders/the sample size of the group) x100%.
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Weekly response rate of abdominal pain
The responder is defined when the following two points are met simultaneously： ①Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).
②Fecal traits: the number of days and frequency with type 6 or 7 stool traits in a week is remained unchanged or decreased from baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.
The response rate=(the number of the responders/the sample size of the group) x100%.
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS symptom severity scale（IBS-SSS）scores
There are five questions in the scale, each of which has a full score of 100 points and a total score of 500 points. The higher the total score, the more serious the patient's symptoms.
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Stool frequency
Daily average number of spontaneous defecation in a week.
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS quality of life (IBS-QOL) scores
The scale consists of 34 items, and each item is divided into five grades: asymptomatic, mild, moderate, overweight, and severe, with corresponding scores of 1-5. The higher the total score, the more serious the patient's symptoms.
Measured: 6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start30 Jan 2023
- Primary completion29 Apr 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mei Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Han, Beijing University of Chinese Medicine
- Investigators
- Wei Wei, Pro, Principal investigator, Wangjing Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687435
- Sponsor's protocol ID
- CYNT-2022-12
- Status last verified
- Mar 2025
- First submitted
- 23 Dec 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05687435
- Acronym / sponsor ID
- CYNT-2022-12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mei HanUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients?
- Is Changchangning Tablet safe for the treatment of IBS-D?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Changyanning group | Experimental | Drug: Changyanning tabletChangyanning tablet: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. |
| Placebo group | Placebo comparator | Other: Changyanning tablet placeboChangyanning tablet placebo: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
- Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changyanning tabletChangyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation. | Drug | Changyanning group |
| Changyanning tablet placeboChangyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation. | Other | Placebo group |
Primary outcome
Weekly response rate of abdominal pain and diarrhea
Time frame: 8 weeks (after treatment)
The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%.
6 secondary outcomes
Weekly response rate of abdominal pain and diarrhea
Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Weekly response rate of diarrhea
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Weekly response rate of abdominal pain
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS symptom severity scale（IBS-SSS）scores
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Stool frequency
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS quality of life (IBS-QOL) scores
Time frame: 6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wei, Pro principal investigator
Wangjing Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Changyanning tablet in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by Mei Han at 1 site 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly response rate of abdominal pain and diarrhea (time frame: 8 weeks (after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.