Diarrhea-predominant Irritable Boewl SyndromePhase 3NCT06753890
Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)
A Phase 3 study testing Changkang granules in people with Diarrhea-predominant Irritable Boewl Syndrome, run by Tasly Pharmaceutical Group Co., Ltd at 30 sites in China.
Trial summary
This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea-predominant Irritable Boewl Syndrome
- What is being tested?
- Changkang granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 30 sitesChina
- Study dates
- 30 Dec 2024to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participants must meet all of the following inclusion criteria to be eligible for this trial:
- Age 18-65 years (inclusive), regardless of gender;
- Meet the Western medical diagnostic criteria for Irritable Bowel Syndrome with Predominant Diarrhea (Rome IV);
- Meet the Traditional Chinese Medicine diagnostic criteria for Liver qi affecting the spleen pattern
- Have a weekly average NRS score for abdominal pain ≥3.0 during the Run-In Period period, and have at least 2 days per week with stool form of type 6 or 7 (Bristol Stool Scale) during the Run-in period;
- Have an IBS-SSS score >175 at baseline;
- Have completed a colonoscopy within the past 12 months prior to the Run-in period, and meet one of the following conditions: ① Normal colonoscopy results with no organic changes; ② Abnormal colonoscopy report, such as hemorrhoids, polyps (diameter ≤5mm and number ≤3), etc., which the investigator determines can be included; ③ Previous colonoscopy report indicating polyps >5mm in diameter or >3 in number, which after endoscopic treatment 6 months ago, residual polyps are ≤5mm in diameter and ≤3 in number, and the investigator determines can be included;
- Voluntarily sign the informed consent form, and from the time of signing the informed consent form until the end of the last visit of the trial, the participant voluntarily accepts health education and maintains their usual diet and lifestyle, such as not changing dietary structure or exercise patterns.
Who cannot join
- Subjects with any of the following conditions are not eligible for enrollment in this study:
- Subjects who have less than 3 spontaneous bowel movements per week during the run-in period; or at least 2 days per week during the run-in period with stool consistency classified as type 1 or 2 on the Bristol Stool Scale;
- Patients with a history of severe mental or psychological disorders, or those scoring ≥63 on the Self-Rating Depression Scale (SDS), or ≥60 on the Self-Rating Anxiety Scale (SAS) during the screening period;
- Patients with a confirmed history of organic gastrointestinal diseases, including both gastrointestinal and non-gastrointestinal digestive system diseases, such as chronic superficial gastritis with erosions or bleeding of grade II or higher, chronic atrophic gastritis, peptic ulcers, inflammatory bowel disease, intestinal tuberculosis, intestinal ulcers, intestinal obstruction, intestinal adhesions, eosinophilic gastroenteritis, cholelithiasis with recurrent cholecystitis (patients with gallstones or gallbladder polyps ≤0.5 cm in diameter and no significant symptoms may be exempted from exclusion upon investigator's judgment), tuberculous peritonitis, liver cirrhosis, and digestive system tumors, etc.;
- Patients diagnosed with other diseases that affect the evaluation of abdominal pain and diarrhea, such as diarrhea caused by lactose intolerance, diarrhea after cholecystectomy, abdominal pain due to endometriosis, abdominal pain caused by hepatic and biliary stones or cholecystitis, abdominal pain due to chronic pancreatitis, etc.;
- Patients with a history of systemic diseases affecting gastrointestinal function, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (such as allergic colitis, allergic purpura, Behcet's syndrome, systemic lupus erythematosus), etc.;
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- Patients with a history of major abdominal surgery involving the gastrointestinal tract, liver, gallbladder, spleen, or pancreas (subjects who have undergone appendectomy or cesarean section without impact on gut function may be exempted from exclusion upon investigator's judgment);
- Patients with unexplained recurrent positive fecal occult blood, unintentional weight loss, anemia, fever, or jaundice prior to screening;
- Abnormal liver function at baseline (ALT or AST >1.5 times the upper limit of normal) or abnormal renal function at baseline (Cr >upper limit of normal);
- Patients with a history of severe diseases in the respiratory, cardiovascular, cerebral, hepatic, renal, endocrine, immune, hematopoietic systems, as well as tumors and neurological diseases, deemed unsuitable for participation in this trial by the investigator;
- Patients who have used prokinetic agents, anticholinergic drugs, calcium channel blockers (excluding antihypertensive drugs), 5-HT3 receptor antagonists, antidiarrheals, antidepressants, anxiolytics, probiotics, analgesics, laxatives, etc., within 4 weeks before randomization;
- Patients who took rescue medication (piroxicam) during the run-in period;
- Pregnant or breastfeeding women, or those planning to conceive within 1 month after enrollment until the end of the trial;
- Patients suspected or known to be allergic to the investigational drug, rescue medication, or its components;
- Patients suspected or known to have a history of alcohol or drug abuse;
- Patients who participated in another interventional clinical trial and took investigational drugs within 1 month before screening;
- Patients whom the investigator deems unsuitable for clinical trial participation for any other reason.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Baoding First Traditional Chinese Medicine Hospital
Baoding
Lipu Wang, 15731291826, Wlip119@sina.com
No. 5, Beixiange Street, Xuanwu District, Beijing
Beijing
Zhen Liu, 13581553766, doctorliuzhen@126.com
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha
Juan ni Zeng, 15084991029, 575826199@qq.com
Changde Second People's Hospital
Chengde
Xianyi Wang, 15200660605, 10405156@qq.com
Chengdu Shuangliu District First People's Hospital
Chengdu
Mei Hua Wan, 18980606316, wanmh@scu.edu.cn
Sichuan University West China Hospital
Chengdu
Wenfu Tang, 18980602098, wftang900@126.com
Guangzhou First People's Hospital
Guangzhou
Zhejiang Provincial Tongde Hospital
Hangzhou
Baoying Fei, 13968124649, 3145681515@qq.com
Zhejiang Xinhua Hospital
Hangzhou
Jihong Zhong, 13186966828, 49747048@qq.com
Kaifeng City Traditional Chinese Medicine Hospital
Kaifeng
Qinghua Zhao, 18637889139, zhaoqinghua2008@126.com
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou
Xudong Tian, 15002591589, xytxd@163.com
Luoyang Central Hospital
Luoyang
Hongwei Chen, 18537919005, chhw.happy@163.com
Luoyang First People's Hospital
Luoyang
Hongling Liu, 18538882095, 1023155248@qq.com
Jiangxi University of Traditional Chinese Medicine Affiliated Hospital
Nanchang
Ling He, 13870621725, heling118@126.com
Nanjing Traditional Chinese Medicine Hospital
Nanjing
Qin Yang, 15380881269, yangqin69@sina.com
Guangxi Traditional Chinese Medicine University Affiliated Rui Kang Hospital
Nanning
Tao Zhang, 13788403729, 327664246@qq.com
Sanmenxia Central Hospital
Sanmenxia
Xuemin Zhai, 13929757803, 1212746278@qq.com
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Shanghai
Jiang Lin, 18917763419, linjiang@longhua.net
Liaoning University of Traditional Chinese Medicine Third Affiliated Hospital
Shenyang
Yue Dong Liu, 18940183370, 13998359001@126.com
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang
Qian Yang, 13832355120, yang0311qian@126.com
Hebei Provincial People's Hospital
Shijiazhuang
Gaifang Liu, 18533112980, liugaifang65@126.com
Tianjin University of Traditional Chinese Medicine Second Affiliated Hospital
Tianjin
Hui Zhen Li, 13212067169, ctjenny@126.com
Wenzhou Medical University Affiliated Second Hospital
Wenzhou
Dingyuan Hu, 13738739934, Dingyuan.hu@wzhealth.com
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou
Yaoming Zeng, 13867704929, 250858111@qq.com
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan
Heng Fan, 18971088538, fanheng009@aliyun.com
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan
Yunlian Hu, 13871061639, 843214365@qq.com
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi'an
tao Yu, 13991252626, yt0745@163.com
Shanxi University of Chinese Medicine Affiliated Hospital
Xianyang
Jiehong Wang, 15091063809, Wangjiehong68@163.com
The Second Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang
Fengli Zhang, 13571045411, 444519560@qq.com
Yangquan Coal Industry (Group) Co., Ltd. General Hospital
Yangquan
Jianming Wang, 13834032799, wnjamn@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea ( Liver qi Affecting the Spleen Pattern)
This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)
Read the detailed description
This Randomized, Double-blind, Placebo-controlled, Multicenter Phase III clinical trial will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)
- Being tested
- Changkang granules, Changkang Granules placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changkang granulesDrug
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang Granules placeboDrug
7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Changkang granules | Experimental | 7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. Receives: Drug: Changkang granules |
| Changkang granules Placebo | Placebo comparator | 7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. Receives: Drug: Changkang Granules placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal pain response rate
The primary efficacy endpoint is the weekly response rate to abdominal pain after 4 weeks of treatment.
Measured: 4 week
Secondary outcomes (11)
The change in the average weekly score of abdominal pain compared to baseline
Starting from the import period, subject diary cards will be collected, and the subjects will rate the "most severe abdominal pain in the past 24 hours" daily. The non empty diary card information of the subjects in the random first 7 days of the import period will be used as the baseline. Calculate the average weekly abdominal pain compared to baseline.
Measured: Baseline, Week 1，Week 2，week3 and week4
Weekly Composite Response Rate
Calculate the proportion of subjects with composite responses over a 4-week period. The intensity of abdominal pain and stool characteristics were obtained from diary cards, with non empty diary card information from participants in the first 7 days of randomization as the baseline. Effective subjects are defined as those who simultaneously meet the following efficacy criteria for at least 50% of the observation period.
Measured: 4 week
The change in total IBS-SSS score and each individual item score from baseline
Irritable bowel syndrome symptom severity scale(IBS-SSS)is a scale to assess the severity of illness in patients with irritable bowel syndrome.The scale has a total score of 500, with a minimum score of 0. Higher scores indicate more severe IBS-related symptoms.The IBS-SSS scale includes an evaluation of five dimensions: degree of abdominal pain, frequency of abdominal pain and bloating, satisfaction with bowel movements, and impact on quality of life (Appendix 2). The total IBS-SSS scores and changes in each dimension from baseline were compared between the two groups.
Measured: 4 week
The change in total IBS-SSS score and each individual item score from baseline
Irritable bowel syndrome symptom severity scale(IBS-SSS)is a scale to assess the severity of illness in patients with irritable bowel syndrome.The scale has a total score of 500, with a minimum score of 0. Higher scores indicate more severe IBS-related symptoms.The IBS-SSS scale includes an evaluation of five dimensions: degree of abdominal pain, frequency of abdominal pain and bloating, satisfaction with bowel movements, and impact on quality of life (Appendix 2).Calculate the total IBS-SSS scores at 3 and 6 weeks after discontinuation, as well as the changes in scores for each dimension compared to baseline.
Measured: up to 10 week
Weekly stool consistency response rate
Fecal trait responders are defined as subjects who meet the efficacy criteria for fecal trait during at least 50% of the observation period (with at least one reduction of at least 50% in the number of days with type 6 or 7 fecal trait compared to baseline per week), and whose abdominal pain intensity remains unchanged or has improved.
Measured: 4 week
The change in the number of days with stool type 6/7 compared to the baseline
Compare the changes in the number of days with 6/7 bowel movements per week during the treatment period compared to baseline.
Measured: Baseline,Week1,Week2,Week3 and Week4
The change in the number of stool type 6/7 compared to baseline
Compare the changes in the frequency of bowel movements of type 6/7 per week during the treatment period compared to baseline.
Measured: Baseline, Week 1，Week 2，week3 and week4
The changes in traditional chinese medicine syndrome score from baseline
Researchers used the IBS-D Liver Qi Multiplying Spleen Syndrome Scale to ask participants about traditional Chinese medicine syndrome related questions, fill out the scale, calculate the total score, and compare the changes in traditional Chinese medicine syndrome scores from baseline over the course of 4 weeks; Simultaneously calculate the change in TCM syndrome score from baseline for 2 weeks.The minimum score is 0 points, and the maximum score is 27 points. The higher the score, the worse it is.
Measured: 4 week
The proportion of subjects with effective improvement in TCM syndrome score
Calculate the proportion of subjects who have effectively improved their TCM syndrome score over a period of 4 weeks.
Measured: 4 week
The change in the score of individual item of TCM symptoms compared to baseline
Compare the changes in individual symptom scores of traditional Chinese medicine over a 4-week period compared to baseline.
Measured: 4 week
The decrease percentage of individual TCM symptoms compared to baseline
Compare the percentage decrease of individual symptoms in traditional Chinese medicine over a period of 4 weeks.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion11 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant Irritable Boewl SyndromeStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753890
- Sponsor's protocol ID
- TSL-TCM-CKKL-III
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea ( Liver qi Affecting the Spleen Pattern)
- ClinicalTrials.gov ID
- NCT06753890
- Acronym / sponsor ID
- TSL-TCM-CKKL-III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Dec 2024 (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.
This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)
Detailed description
This Randomized, Double-blind, Placebo-controlled, Multicenter Phase III clinical trial will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)
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 |
|---|---|---|
| Changkang granules | Experimental | Drug: Changkang granules7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. |
| Changkang granules Placebo | Placebo comparator | Drug: Changkang Granules placebo7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following inclusion criteria to be eligible for this trial:
Key exclusion criteria (17 listed)
- Subjects with any of the following conditions are not eligible for enrollment in this study:
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 |
|---|---|---|
| Changkang granules7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. | Drug | Changkang granules |
| Changkang Granules placebo7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks. | Drug | Changkang granules Placebo |
Primary outcome
abdominal pain response rate
Time frame: 4 week
The primary efficacy endpoint is the weekly response rate to abdominal pain after 4 weeks of treatment.
11 secondary outcomes
The change in the average weekly score of abdominal pain compared to baseline
Time frame: Baseline, Week 1，Week 2，week3 and week4
Weekly Composite Response Rate
Time frame: 4 week
The change in total IBS-SSS score and each individual item score from baseline
Time frame: 4 week
The change in total IBS-SSS score and each individual item score from baseline
Time frame: up to 10 week
Weekly stool consistency response rate
Time frame: 4 week
The change in the number of days with stool type 6/7 compared to the baseline
Time frame: Baseline,Week1,Week2,Week3 and Week4
The change in the number of stool type 6/7 compared to baseline
Time frame: Baseline, Week 1，Week 2，week3 and week4
The changes in traditional chinese medicine syndrome score from baseline
Time frame: 4 week
The proportion of subjects with effective improvement in TCM syndrome score
Time frame: 4 week
The change in the score of individual item of TCM symptoms compared to baseline
Time frame: 4 week
The decrease percentage of individual TCM symptoms compared to baseline
Time frame: 4 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Changkang granules in people with Diarrhea-predominant Irritable Boewl Syndrome, run by Tasly Pharmaceutical Group Co., Ltd at 30 sites 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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal pain response rate (time frame: 4 week). 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 31 Dec 2024.