Irritable Bowel SyndromePhase 2TCM-IBSNCT00676975
The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome
A Phase 2 study testing Traditional Chinese Medicine in people with Irritable Bowel Syndrome, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of quality of life of patients with Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Traditional Chinese Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2008to 30 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All IBS patients attending the Gastroenterology Clinic of the Prince of Wales Hospital of Hong Kong.
- Age 18-75 inclusive
- IBS diagnosed by Rome III criteria:
- Recurrent abdominal pain or discomfort at least three days per month in the previous three months
- Symptom onset at least six months prior to diagnosis
- Pain or discomfort associated with two or more of the following:
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- Improvement with defecation
- Onset associated with a 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 baseline and during the two-week run-in period
- 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 diseases (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 abuse
- Current psychiatric illness or dementia
- Fever or severe illness at baseline (week 0).
Trial locations and contacts
1 site in 1 country.
China1 site
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
Hong Kong (sar), 852
About this study
Official title: Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome(TCM- IBS)
To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of quality of life of patients with Irritable Bowel Syndrome.
Read the detailed description
Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in treating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of IBS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. A methodologically strong trial of a 20-herb formula has shown significant benefit for IBS patients. However, the herbal formulation was inadequately characterized and defined for repeated clinical studies.
Subsequent to complete chemical characterization, a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial will be conducted to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 104 patients aged 18 to 75 with all types of IBS. At each of two dosage levels, 52 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 1:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st dosage level, safety will be assessed prior to using the higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequency of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by dose counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional pharmaceuticals.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Traditional Chinese Medicine, Traditional Chinese Medicine Placebo
- Keywords
- Irritable Bowel disease, Traditional Chinese Medicine
- 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.
Traditional Chinese MedicineDrug
A herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage.
The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale
Traditional Chinese Medicine PlaceboDrug
Placebo once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Active comparator | Traditional Chinese Medicine 17g herbal extract Receives: Drug: Traditional Chinese Medicine |
| Traditional Chinese Medicine Placebo | Placebo comparator | Placebo Receives: Drug: Traditional Chinese Medicine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no)
Measured: 12 weeks
Secondary outcomes (1)
Bowel Symptom Scale (BSS): to assess changes in individual IBS and global IBS symptoms. QoL assessment:one disease-specific (IBS-QoL) and one generic (SF-36), will be used.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study start26 May 2008
- Primary completion30 Dec 2010
- Study completion30 Aug 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 Chinese University of Hong KongThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
- Investigators
- Francis KL Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676975
- Sponsor's protocol ID
- TCM-IBS
- Other IDs
- 1U19AT003266-01
- Acronym
- TCM-IBS
- Status last verified
- Apr 2017
- First submitted
- 9 May 2008
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. 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(TCM- IBS)
- ClinicalTrials.gov ID
- NCT00676975
- Acronym / sponsor ID
- TCM-IBS / TCM-IBS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel disease, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University of Maryland, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 May 2008 (actual)
- Primary completion
- 30 Dec 2010 (actual)
- Study completion
- 30 Aug 2011 (actual)
- First posted
- 13 May 2008 (estimated)
- 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.
To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of quality of life of patients with Irritable Bowel Syndrome.
Detailed description
Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in treating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of IBS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. A methodologically strong trial of a 20-herb formula has shown significant benefit for IBS patients. However, the herbal formulation was inadequately characterized and defined for repeated clinical studies.
Subsequent to complete chemical characterization, a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial will be conducted to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 104 patients aged 18 to 75 with all types of IBS. At each of two dosage levels, 52 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 1:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st dosage level, safety will be assessed prior to using the higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequency of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by dose counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional pharmaceuticals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Active comparator | Drug: Traditional Chinese MedicineTraditional Chinese Medicine 17g herbal extract |
| Traditional Chinese Medicine Placebo | Placebo comparator | Drug: Traditional Chinese Medicine PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All IBS patients attending the Gastroenterology Clinic of the Prince of Wales Hospital of Hong Kong.
- Age 18-75 inclusive
- 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 baseline and during the two-week run-in period
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 diseases (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 |
|---|---|---|
| Traditional Chinese MedicineA herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage. The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale | Drug | Traditional Chinese Medicine |
| Traditional Chinese Medicine PlaceboPlacebo once daily for 8 weeks | Drug | Traditional Chinese Medicine Placebo |
Primary outcome
Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no)
Time frame: 12 weeks
1 secondary outcome
Bowel Symptom Scale (BSS): to assess changes in individual IBS and global IBS symptoms. QoL assessment:one disease-specific (IBS-QoL) and one generic (SF-36), will be used.
Time frame: 12 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 25 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Francis KL Chan, MD principal investigator
Chinese University of Hong Kong
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 Traditional Chinese Medicine in people with Irritable Bowel Syndrome, run by Chinese University of Hong Kong at 1 site in China.
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 25 Apr 2017. 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 China. 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?
Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no) (time frame: 12 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 25 Apr 2017.