Irritable Bowel Syndrome with DiarrheaPhase 2NCT04492787
Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study testing Changkang Granule in people with Irritable Bowel Syndrome with Diarrhea, run by Tasly Pharmaceutical Group Co., Ltd at 8 sites in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome with Diarrhea
- What is being tested?
- Changkang Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- 6 Jul 2020to 21 Apr 2022
- Phase
- Phase 2
- 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
- The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
- It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
- Male or female aged 18 to 65 years (including the boundary value);
- The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
- IBS-SSS score>175;
- Signed informed consent voluntarily.
Who cannot join
- Patients with IBS-C、IBS-M or IBS-U；
- Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
- Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
- Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
- Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
- With history of abdominal surgery (e.g., cholecystectomy);
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- Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
- Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
- Taking emergency medication in the run-in period；
- Pregnant or lactating women；
- Those who are allergic to the test drug, emergency drug and its ingredients；
- Suspected or confirmed history of alcohol and drug abuse;
- Patients who participated in other clinical trials within one month before enrollment;
- The researchers believe that others are not suitable for clinical trials.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Beijing
Shengjing Hospital of China Medical University
Dalian
Gansu Provincial Hospital of TCM
Gansu
The first affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hunan
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
West China Hospital of Sichuan University
Sichuan
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
About this study
Official title: A Randomized,double-blind,placebo-controlled,multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.
Read the detailed description
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.
Patients report their IBS-related symptoms daily from run-in until end of treatment.
- Conditions
- Irritable Bowel Syndrome with Diarrhea
- Being tested
- Changkang Granule, Changkang Placebo Granule
- Keywords
- Changkang Granule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changkang GranuleDrug
Take Changkang granule before meals twice a day , one bag for each time
Changkang Placebo GranuleDrug
Take Changkang Placebo granule before meals twice a day , one bag for each time
| Study group | Role | What they receive |
|---|---|---|
| Changkang Granules | Experimental | Changkang Granules Receives: Drug: Changkang Granule |
| Changkang Placebo Granules | Placebo comparator | Changkang Placebo Granules Receives: Drug: Changkang Placebo Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Composite Responders Consistency Scores
Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.
The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week.
- Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
- Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Measured: 8 week
Secondary outcomes (8)
Percentage of Participants Who Are Responders in Abdominal Pain Scores
Abdominal pain responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval; Weekly response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.
Measured: 8 week
Percentage of Participants Who Are Responders in Stool Consistency Scores
Stool consistency responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.
Weekly response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Measured: 8 week
Change from baseline to each week during follow up for IBS-symptoms abdominal pain；
Abdominal Pain：Scored between 0 and 10 (none to severe).
Measured: 8 week
Change from baseline to each week during follow up for IBS-symptoms stool consistency;
Stool consistency：Bristol Stool Scale（Scored 1-7）.
Measured: 8 week
Change from baseline to each week during follow up for IBS-symptoms bloating
Bloating：Scored between 0 and 10.
Measured: 8 week
Change from baseline to each week during follow up for IBS-symptoms urgency
The change of frequency of defecation urgency per week compared with baseline.
Measured: 8 week
Change from baseline to each week during follow up for IBS-symptoms Defecation frequency
Change from baseline in mean number of bowel movements per week.
Measured: 8 week
Disappearance rate of traditional Chinese Medicine（TCM）symptom
Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start6 Jul 2020
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome with DiarrheaStudies 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 2
- 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
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492787
- Sponsor's protocol ID
- TSL-TCM-CKKL-Ⅱ
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2020
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,double-blind,placebo-controlled,multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT04492787
- Acronym / sponsor ID
- TSL-TCM-CKKL-Ⅱ
- Conditions
- Irritable Bowel Syndrome with Diarrhea
- Keywords
- Changkang Granule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 30 Jul 2020 (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 aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.
Detailed description
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.
Patients report their IBS-related symptoms daily from run-in until end of treatment.
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 GranuleChangkang Granules |
| Changkang Placebo Granules | Placebo comparator | Drug: Changkang Placebo GranuleChangkang Placebo Granules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
- It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
- Male or female aged 18 to 65 years (including the boundary value);
- The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
- IBS-SSS score>175;
Key exclusion criteria (14 listed)
- Patients with IBS-C、IBS-M or IBS-U；
- Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
- Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
- Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
- Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
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 GranuleTake Changkang granule before meals twice a day , one bag for each time | Drug | Changkang Granules |
| Changkang Placebo GranuleTake Changkang Placebo granule before meals twice a day , one bag for each time | Drug | Changkang Placebo Granules |
Primary outcome
Percentage of Participants Who Are Composite Responders Consistency Scores
Time frame: 8 week
Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week. 1. Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; 2. Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
8 secondary outcomes
Percentage of Participants Who Are Responders in Abdominal Pain Scores
Time frame: 8 week
Percentage of Participants Who Are Responders in Stool Consistency Scores
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms abdominal pain；
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms stool consistency;
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms bloating
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms urgency
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms Defecation frequency
Time frame: 8 week
Disappearance rate of traditional Chinese Medicine（TCM）symptom
Time frame: 8 week
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 5 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Changkang Granule in people with Irritable Bowel Syndrome with Diarrhea, run by Tasly Pharmaceutical Group Co., Ltd at 8 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 6 inclusion and 14 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of Participants Who Are Composite Responders Consistency Scores (time frame: 8 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 5 Sep 2024.