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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Changkang Granules | Experimental | Changkang Granules |
|
| Changkang Placebo Granules | Placebo Comparator | Changkang Placebo Granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Changkang Granule | Drug | Take Changkang granule before meals twice a day , one bag for each time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital, China Academy of Traditional Chinese Medicine | Beijing | China | ||||
| Shengjing Hospital of China Medical University |
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| Changkang Placebo Granule | Drug | Take Changkang Placebo granule before meals twice a day , one bag for each time |
|
| 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. | 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). | 8 week |
| Change from baseline to each week during follow up for IBS-symptoms stool consistency; | Stool consistency:Bristol Stool Scale(Scored 1-7). | 8 week |
| Change from baseline to each week during follow up for IBS-symptoms bloating | Bloating:Scored between 0 and 10. | 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. | 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. | 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 | 8 week |
| Dalian |
| China |
| Gansu Provincial Hospital of TCM | Gansu | China |
| The first affiliated Hospital of Hunan University of Traditional Chinese Medicine | Hunan | China |
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | China |
| West China Hospital of Sichuan University | Sichuan | China |
| Wenzhou Hospital of Traditional Chinese Medicine | Wenzhou | China |
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | China |