Irritable Bowel SyndromePhase 2TCM-IBSNCT03300804
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
A Phase 2 study testing 20-herb formulation in people with Irritable Bowel Syndrome, run by University of Maryland, Baltimore at 1 site in Hong Kong.
Trial summary
The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- 20-herb formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2008to Jun 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 75
- All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.
- IBS diagnosed by Rome III criteria:
- Recurrent abdominal pain or discomfort at least three days per month in the previous three months
- Symptoms onset at least six months prior to diagnose
- Pain or discomfort associated with two or more of the following:
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- Improvement with defecation
- Onset associated with change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
- No "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline
- Normal full blood count, liver function test and renal function test.
- Informed written consent for participation into study.
- Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.
Who cannot join
- Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained.
- Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
- Lactose intolerance
- Severe liver disease (e.g. cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level > 150mmol/L)
- Women who are pregnant, lactating or not practicing proper contraception
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- Known hypersensitivity to herbal medicine
- Concommitant use of prescription antidepressant medication
- Current alcoholism and drug use
- Current psychiatric illness or dementia
- Fever or severe illness at baseline (week 0).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong
Shatin
About this study
Official title: Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome
The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.
Read the detailed description
The Specific aims of the project are:
- To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine.
- To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- 20-herb formulation, Placebo
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-herb formulationDrug
Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks
PlaceboDrug
Placebo herb formulation
| Study group | Role | What they receive |
|---|---|---|
| 20-herb formulation | Active comparator | Active herb Receives: Drug: 20-herb formulation |
| Placebo | Placebo comparator | Placebo herb formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global IBS symptom improvement
The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.
Measured: 8 weeks
Secondary outcomes (3)
The Bowel Symptom Scale (BSS):
The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.
Measured: 8 weeks
SF-36
Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
Measured: 8 weeks
IBS-QoL
Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study startMay 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Brian Berman, University of Maryland, Baltimore
- Investigators
- Brian M Berman, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300804
- Sponsor's protocol ID
- HP-00041236
- Other IDs
- 1U19AT003266-01
- Acronym
- TCM-IBS
- Status last verified
- Feb 2022
- First submitted
- 28 Mar 2010
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03300804
- Acronym / sponsor ID
- TCM-IBS / HP-00041236
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Oct 2017 (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.
The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.
Detailed description
The Specific aims of the project are:
- To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine.
- To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-herb formulation | Active comparator | Drug: 20-herb formulationActive herb |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo herb formulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18- 75
- All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.
- IBS diagnosed by Rome III criteria:
- Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
- No "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline
Key exclusion criteria (11 listed)
- Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained.
- Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
- Lactose intolerance
- Severe liver disease (e.g. cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level > 150mmol/L)
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 |
|---|---|---|
| 20-herb formulationTwo daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks | Drug | 20-herb formulation |
| PlaceboPlacebo herb formulation | Drug | Placebo |
Primary outcome
Global IBS symptom improvement
Time frame: 8 weeks
The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.
3 secondary outcomes
The Bowel Symptom Scale (BSS):
Time frame: 8 weeks
SF-36
Time frame: 8 weeks
IBS-QoL
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Brian M Berman, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20-herb formulation in people with Irritable Bowel Syndrome, run by University of Maryland, Baltimore at 1 site in Hong Kong.
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 14 inclusion and 11 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: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global IBS symptom improvement (time frame: 8 weeks). 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 14 Mar 2022.