A Chinese Herbal Medicine for IBS-C (CDD2105RCT1)

March 20, 2024 updated by: ZhaoXiang Bian, Hong Kong Baptist University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from baseline to Week 4
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.
from baseline to Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10)
Time Frame: from baseline to Week 4
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
Time Frame: from baseline to Week 4
weekly number of days of abdominal pain
from baseline to Week 4
Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency
Time Frame: from baseline to Week 4
weekly Complete Spontaneous Bowel Movement (CSBM) frequency
from baseline to Week 4
Change in the average weekly Spontaneous Bowel Movement (SBM) frequency
Time Frame: from baseline to Week 4
weekly Spontaneous Bowel Movement (SBM)
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
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)
Time Frame: from baseline to Week 4
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
Time Frame: from baseline to Week 4
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
Time Frame: from baseline to Week 4
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)
Time Frame: from baseline to Week 4
Assessed by liver and renal related index in blood samples
from baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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