A Chinese Herbal Medicine for IBS-C (NCT06319729) | Clinical Trial Compass
UnknownPhase 2
A Chinese Herbal Medicine for IBS-C
78 participantsStarted 2024-03-25
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-65 years adults
* Fulfill the clinically diagnosed with IBS-C based on the ROME IV criteria
* Abdominal pain intensity: weekly average of the worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0 to 10 point scale (based on the 2-week E-diary in screening)
* CSBM ≤ 2 times/week (based on the 2-week E-diary in screening)
* Understand and be able to follow written and oral instructions in Chinese
* Provide informed consent
* Able to use and complete 2-week E-diary for screening
Exclusion Criteria:
* Drug-induced or secondary causes of constipation
* Use of medications and/or supplements that may confound the study outcomes (including but not limited to antibiotics, steroid, analgesic drug, neuromodulator, prebiotics, symbiotics, or probiotics)
* Clinically significant colonoscopy or sigmoidoscopy examination findings after the onset of symptoms for patients who (1) is ≥50 years old; and/or (2) has family risk of colon-rectal cancer or familial polyposis syndromes; and/or (3) has alarm symptoms within 6 months before screening (unintentional weight loss: \>10% in 3 months, blood in the stools not caused by hemorrhoids or anal fissures, fever of unknown origin, anemia)
* Clinically significant laboratory or imaging findings within 6 months before screening
* Recent history of mushy or watery stools within one month
* Allergic to Chinese herbal medicine or G6PD
* Abdominal surgeries within the past year (except laparoscopic appendectomy…
What they're measuring
1
Abdominal Pain Responder Rate
Timeframe: from baseline to Week 4
2
Complete Spontaneous Bowel Movement (CSBM) Responder Rate