Colonic Diseases, FunctionalPhase 2NCT00153751
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
A Phase 2 study testing Traditional Chinese Medicine and Holopon in people with Colonic Diseases, Functional, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colonic Diseases, Functional
- What is being tested?
- Traditional Chinese Medicine and Holopon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to May 2007
- 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
- All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study.
- IBS is diagnosed by Rome II criteria [Thompson et al. Gut 2000]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years
- Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period
- Informed written consent for participation into study.
- Ethical approval will be obtained from the Clinical Research Ethics Committee of the University
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
Hong Kong (sar)
About this study
Official title: Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS
To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. Epidemiological studies showed that 14% of males and 27% of females in the US (white) have symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition among Chinese (13% in males and 21% in females). IBS is one of the most common conditions leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory. Numerous medications have been proposed for IBS; however, none is convincingly effective. A review and critique of published drug trials for IBS from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all IBS patients. With the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for IBS. Traditional Chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. However, there is a lack of convincing clinical data demonstrating the effectiveness of Chinese medicine in this condition. In this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type IBS. Patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM), 2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week period of randomized double-blind treatment with either HW, WM or placebo and followed by an 8-week of observation period. The IBS symptom and quality of life will be compared.
- Conditions
- Colonic Diseases, Functional
- Being tested
- Traditional Chinese Medicine, Holopon, placebo
- Keywords
- Traditional Chinese Medicine
- Medical subject headings
- Colonic Diseases, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineDrug
Also called TCM
They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
HoloponDrug
Also called Western Medicine
holopon
placeboOther
Also called dummy
placebo
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Experimental | They are Common peony root, other herbs. Receives: Drug: Traditional Chinese Medicine |
| Holopon | Active comparator | Holopon Receives: Drug: Holopon |
| placebo | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The global assessment of IBS symptom by patients.
Measured: 16 weeks
Secondary outcomes (1)
Individual IBS symptoms and QOL assessment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Diseases, FunctionalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Joseph JY Sung, MD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153751
- Sponsor's protocol ID
- JC_IBS
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS
- ClinicalTrials.gov ID
- NCT00153751
- Acronym / sponsor ID
- JC_IBS
- Conditions
- Colonic Diseases, Functional
- Keywords
- Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2005 (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 herbal medicine in relieving symptoms and change of quality of life of patients with IBS.
Detailed description
Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. Epidemiological studies showed that 14% of males and 27% of females in the US (white) have symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition among Chinese (13% in males and 21% in females). IBS is one of the most common conditions leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory. Numerous medications have been proposed for IBS; however, none is convincingly effective. A review and critique of published drug trials for IBS from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all IBS patients. With the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for IBS. Traditional Chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. However, there is a lack of convincing clinical data demonstrating the effectiveness of Chinese medicine in this condition. In this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type IBS. Patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM), 2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week period of randomized double-blind treatment with either HW, WM or placebo and followed by an 8-week of observation period. The IBS symptom and quality of life will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Experimental | Drug: Traditional Chinese MedicineThey are Common peony root, other herbs. |
| Holopon | Active comparator | Drug: HoloponHolopon |
| placebo | Placebo comparator | Other: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study.
- IBS is diagnosed by Rome II criteria [Thompson et al. Gut 2000]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years
- Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period
- Informed written consent for participation into study.
Key exclusion criteria (0 listed)
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 MedicineAlso: TCMThey are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo. | Drug | Traditional Chinese Medicine |
| HoloponAlso: Western Medicineholopon | Drug | Holopon |
| placeboAlso: dummyplacebo | Other | placebo |
Primary outcome
The global assessment of IBS symptom by patients.
Time frame: 16 weeks
1 secondary outcome
Individual IBS symptoms and QOL assessment
Time frame: 16 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 13 May 2008.
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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.
Joseph JY Sung, MD principal investigator
CUHK
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 and Holopon in people with Colonic Diseases, Functional, 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 6 inclusion and 0 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 13 May 2008. 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?
The global assessment of IBS symptom by patients. (time frame: 16 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 13 May 2008.