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)
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
520
7.5g/bag, 1 bag per dose, 2 doses per day, oral,4 consecutive weeks.
7.5g/bag, 1 bag per dose, 2 doses per day, oral,4 consecutive weeks.
abdominal pain response rate
The primary efficacy endpoint is the weekly response rate to abdominal pain after 4 weeks of treatment.
Time frame: 4 week
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 week
The change in total IBS-SSS score and each individual item score from baseline
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Baoding First Traditional Chinese Medicine Hospital
Baoding, China
No. 5, Beixiange Street, Xuanwu District, Beijing
Beijing, China
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, China
Changde Second People's Hospital
Chengde, China
Chengdu Shuangliu District First People's Hospital
Chengdu, China
Sichuan University West China Hospital
Chengdu, China
Guangzhou First People's Hospital
Guangzhou, China
Zhejiang Provincial Tongde Hospital
Hangzhou, China
Zhejiang Xinhua Hospital
Hangzhou, China
Kaifeng City Traditional Chinese Medicine Hospital
Kaifeng, China
...and 20 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 week