A Chinese Herbal Medicine for IBS-C

NCT ID: NCT06319729

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2024-11-30

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.

Conditions

Constipation-predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

CDD-2105

Intervention Type: DRUG

A Chinese herbal medicine formula containing four granular herbs.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

CDD-2105

A Chinese herbal medicine formula containing four granular herbs.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

ZhaoXiang Bian

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

REC/22-23/0659

Identifier Type: -

Identifier Source: org_study_id