A Chinese Herbal Medicine for IBS-C

Constipation-predominant Irritable Bowel Syndrome Clinical Trial

— CDD2105RCT1  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319729
• Other study ID #: REC/22-23/0659
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• CDD-2105
A Chinese herbal medicine formula containing four granular herbs.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Outcome

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