Clinical trial NCT06319729: A Chinese Herbal Medicine for IBS-C
Official title: The Efficacy and Safety of a Chinese Herbal Medicine for the Constipation-predominant Irritable Bowel Syndrome (IBS-C): a Double-blinded, Placebo-controlled, Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Constipation-predominant Irritable Bowel Syndrome
Keywords: Chinese Herbal Medicine
IBS-C
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo-controlled randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)
* Pregnancy, breastfeeding or plan to become pregnant with the study timeframe
* Any disease(s), condition(s) or habit(s) deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
* Any disease(s), condition(s) or habit(s) deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research, at the discretion of the investigators

Primary outcomes:
measure: Abdominal Pain Responder Rate
timeFrame: from baseline to Week 4
measure: Complete Spontaneous Bowel Movement (CSBM) Responder Rate
timeFrame: from baseline to Week 4
Secondary outcomes:
measure: Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10)
timeFrame: from baseline to Week 4
measure: Change in the number of days of abdominal pain per week
timeFrame: from baseline to Week 4
measure: Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency
timeFrame: from baseline to Week 4
measure: Change in the average weekly Spontaneous Bowel Movement (SBM) frequency
timeFrame: from baseline to Week 4
measure: Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire
timeFrame: from baseline to Week 4
measure: Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM)
timeFrame: from baseline to Week 4
measure: Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire
timeFrame: from baseline to Week 4
measure: Safety: number of adverse events
timeFrame: from baseline to Week 4
measure: Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine)
timeFrame: from baseline to Week 4
Other outcomes:
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