A Chinese Herbal Medicine for IBS-C (CDD2105RCT1)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: CDD-2105

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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: CDD-2105; A Chinese herbal medicine formula containing four granular herbs.
Placebo Comparator: Placebo group; During the 4-week intervention, participants are required to consume 4.7g of placebo twice per day.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	from baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from baseline to Week 4
Change in the number of days of abdominal pain per week	weekly number of days of abdominal pain	from baseline to Week 4
Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency	weekly Complete Spontaneous Bowel Movement (CSBM) frequency	from baseline to Week 4
Change in the average weekly Spontaneous Bowel Movement (SBM) frequency	weekly Spontaneous Bowel Movement (SBM)	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.	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.	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.	from baseline to Week 4
Safety: number of adverse events	Assessed by number of adverse events or side effects	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	from baseline to Week 4

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chinese Herbal Medicine; IBS-C
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: REC/22-23/0659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol, SAP, and de-identified data will be shared upon the researchers' request.
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: researchers' request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No