This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.
This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.Primary Objective: To determine the efficacy and safety of CDD-2105 granules for treating IBS-C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Abdominal Pain Responder Rate
An abdominal pain responder is a patient who meets the abdominal pain weekly responder criterion (i.e., an improvement of ≥30% from the baseline weekly average of the worst abdominal pain in the past 24 hours score to the weekly average during the intervention, in at least 2 out of 4 weeks). Abdominal pain at its worst (in the last 24 hours) is assessed daily by participants on an 11-point numerical rating scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Baseline of weekly abdominal pain will be the average between Week -2 and Week 0.
Time frame: from baseline to Week 4
Complete Spontaneous Bowel Movement (CSBM) Responder Rate
A CSBM responder is defined as a patient who meets the CSBM responder criterion (i.e., a mean increase of CSBM≥1/week compared with CSBM at baseline, in at least 2 out of 4 weeks). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0.
Time frame: from baseline to Week 4
Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10)
weekly average self-assessed daily maximum abdominal pain scores (0-10)
Time frame: from baseline to Week 4
Change in the number of days of abdominal pain per week
weekly number of days of abdominal pain
Time frame: from baseline to Week 4
Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency
weekly Complete Spontaneous Bowel Movement (CSBM) frequency
Time frame: from baseline to Week 4
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Change in the average weekly Spontaneous Bowel Movement (SBM) frequency
weekly Spontaneous Bowel Movement (SBM)
Time frame: from baseline to Week 4
Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire
Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS), 0-500, Mild, moderate and severe cases are indicated by a score of 75 to 175, 175 to 300 and greater than 300, respectively.
Time frame: from baseline to Week 4
Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM)
Patient Assessment of Constipation-Symptoms (PAC-SYM), It is five - grade (0-4)likert scale. The high scores indicate worsening severity of symptoms.
Time frame: from baseline to Week 4
Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire
Patient Assessment of Constipation Quality of Life (PAC-QoL). The PAC-QOL questionnaire is subcategorized to 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4. Higher scores mean higher negative effects on quality of life.
Time frame: from baseline to Week 4
Safety: number of adverse events
Assessed by number of adverse events or side effects
Time frame: from baseline to Week 4
Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine)
Assessed by liver and renal related index in blood samples
Time frame: from baseline to Week 4