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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Take Changkang granule before meals twice a day , one bag for each time
Take Changkang Placebo granule before meals twice a day , one bag for each time
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Beijing, China
Shengjing Hospital of China Medical University
Dalian, China
Gansu Provincial Hospital of TCM
Gansu, China
The first affiliated Hospital of Hunan University of Traditional Chinese Medicine
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. 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.
Time frame: 8 week
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.
Time frame: 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.
Time frame: 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).
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms stool consistency;
Stool consistency:Bristol Stool Scale(Scored 1-7).
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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
Time frame: 8 week
Change from baseline to each week during follow up for IBS-symptoms bloating
Bloating:Scored between 0 and 10.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 8 week