Constipation-predominant Irritable Bowel SyndromePhase 2CDD2105RCT1NCT06319729
A Chinese Herbal Medicine for IBS-C
A Phase 2 study testing CDD-2105 in people with Constipation-predominant Irritable Bowel Syndrome, run by Hong Kong Baptist University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- CDD-2105
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2024to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
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.
Read the 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.
- Being tested
- CDD-2105, Placebo
- Keywords
- Chinese Herbal Medicine, IBS-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDD-2105Drug
A Chinese herbal medicine formula containing four granular herbs.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Drug: CDD-2105 |
| Placebo group | Placebo comparator | During the 4-week intervention, participants are required to consume 4.7g of placebo twice per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to Week 4
Secondary outcomes (9)
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)
Measured: from baseline to Week 4
Change in the number of days of abdominal pain per week
weekly number of days of abdominal pain
Measured: from baseline to Week 4
Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency
weekly Complete Spontaneous Bowel Movement (CSBM) frequency
Measured: from baseline to Week 4
Change in the average weekly Spontaneous Bowel Movement (SBM) frequency
weekly Spontaneous Bowel Movement (SBM)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from baseline to Week 4
Safety: number of adverse events
Assessed by number of adverse events or side effects
Measured: 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
Measured: from baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start25 Mar 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo-controlled randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319729
- Sponsor's protocol ID
- REC/22-23/0659
- Acronym
- CDD2105RCT1
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol, SAP, and de-identified data will be shared upon the researchers' request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06319729
- Acronym / sponsor ID
- CDD2105RCT1 / REC/22-23/0659
- Keywords
- Chinese Herbal Medicine, IBS-C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: CDD-2105During 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. |
| Placebo group | Placebo comparator | Drug: PlaceboDuring the 4-week intervention, participants are required to consume 4.7g of placebo twice per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDD-2105A Chinese herbal medicine formula containing four granular herbs. | Drug | Treatment group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
Abdominal Pain Responder Rate
Time frame: from baseline to Week 4
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.
Complete Spontaneous Bowel Movement (CSBM) Responder Rate
Time frame: from baseline to Week 4
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.
9 secondary outcomes
Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10)
Time frame: from baseline to Week 4
Change in the number of days of abdominal pain per week
Time frame: from baseline to Week 4
Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency
Time frame: from baseline to Week 4
Change in the average weekly Spontaneous Bowel Movement (SBM) frequency
Time frame: from baseline to Week 4
Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire
Time frame: from baseline to Week 4
Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM)
Time frame: from baseline to Week 4
Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire
Time frame: from baseline to Week 4
Safety: number of adverse events
Time frame: from baseline to Week 4
Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine)
Time frame: from baseline to Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes. The protocol, SAP, and de-identified data will be shared upon the researchers' request.
Related trials for Constipation-predominant Irritable Bowel Syndrome
Not yet recruitingPhase 4
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)
Not yet recruitingObservational study
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation
Constipation, Constipation - Functional
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDD-2105 in people with Constipation-predominant Irritable Bowel Syndrome, run by Hong Kong Baptist University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Pain Responder Rate (time frame: from baseline to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.