A Chinese Herbal Medicine for IBS-C (CDD2105RCT1)

Hong Kong Baptist University

Status and phase: Not yet enrolling; Phase 2

Conditions: Constipation-predominant Irritable Bowel Syndrome

Treatments: Drug: CDD-2105; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06319729

REC/22-23/0659

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

During the 4-week intervention, participants are required to consume 4.7g of CDD-2105 granule (a Chinese herbal medicine formula containing four granular herbs) twice per day.

Treatment:

Drug: CDD-2105

Placebo group

Placebo Comparator group

Description:

During the 4-week intervention, participants are required to consume 4.7g of placebo twice per day.

Treatment:

Drug: Placebo