Diarrhea-predominant Irritable Bowel SyndromePhase 2/3NCT01350570
Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
A Phase 2/3 study testing acupuncture, acupuncture group2 and acupuncture group3 in people with Diarrhea-predominant Irritable Bowel Syndrome and Functional Diarrhea, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome, Functional Diarrhea
- What is being tested?
- acupuncture, acupuncture group2 and acupuncture group3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Sep 2014
- Phase
- Phase 2/3
- 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
- Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
- Age between 18 and 65 years old;
- Did not take any medicine for bowel symptoms and attend other clinical research;
- Have inform consent signed.
Who cannot join
- Diarrhea caused by diseases such as infection, etc.
- Patients can't express himself clearly or with mental diseases;
- Tumor and other infectious diseases;
- With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital of Chengdu university of TCM
Chengdu, Sichuan, 610075
About this study
Official title: Acupuncture for Functional Bowel Disease
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.
Read the detailed description
Outcome measurements:
The frequency of bowel movement; The bristol stool scale; SF-36 evaluation
- Being tested
- acupuncture, acupuncture group2, acupuncture group3, Loperamide
- Keywords
- acupuncture, loperamide, functional diarrhea, IBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called Acupuncture at Shumu acupoints
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
acupuncture group2Other
Also called Acupuncture at He acupoints
Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
acupuncture group3Other
Also called Acupuncture at Shumu and He acupoints
All acupoints used in acupuncture group1 and group2 will be used in this group.
LoperamideDrug
Also called Luopaidingan
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group 1 | Experimental | Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back. Receives: Other: acupuncture |
| acupuncture group 2 | Experimental | Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb. Receives: Other: acupuncture group2 |
| acupuncture group 3 | Experimental | All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group. Receives: Other: acupuncture group3 |
| Loperamide | Active comparator | Loperamide will be used as an active comparator to the acupuncture groups. Receives: Drug: Loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weekly stool frequency
Average weekly stool frequency, change from baseline in 4 weeks
Measured: 4th week after inclusion
Secondary outcomes (3)
Assessment score of Bristol stool scale
Bristol stool scale was designed to classify the human stool into 7 categories.
The seven types of stool are:
Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid
Measured: 4th and 8th week after inclusion
Assessment score of SF-36 scale
The Short Form (36) Health Survey (SF-36) is a survey of patient health. The SF-36 is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The chinese version of SF-36 was validated and has been widely used in acupuncture studies.
Measured: 4th and 8th after inclusion
Number of patients with adverse events after treatment
Number of patients with adverse events after treatment will be recorded and compared among three groups.
Measured: 4th week after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Ying Li, MD, PhD, Principal investigator, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350570
- Sponsor's protocol ID
- 2011CB5200-Fd
- Status last verified
- Apr 2015
- First submitted
- 6 May 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Functional Bowel Disease
- ClinicalTrials.gov ID
- NCT01350570
- Acronym / sponsor ID
- 2011CB5200-Fd
- Keywords
- acupuncture, loperamide, functional diarrhea, IBS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 May 2011 (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.
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.
Detailed description
Outcome measurements:
The frequency of bowel movement; The bristol stool scale; SF-36 evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupuncture group 1 | Experimental | Other: acupunctureAcupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back. |
| acupuncture group 2 | Experimental | Other: acupuncture group2Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb. |
| acupuncture group 3 | Experimental | Other: acupuncture group3All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group. |
| Loperamide | Active comparator | Drug: LoperamideLoperamide will be used as an active comparator to the acupuncture groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
- Age between 18 and 65 years old;
- Did not take any medicine for bowel symptoms and attend other clinical research;
- Have inform consent signed.
Key exclusion criteria (4 listed)
- Diarrhea caused by diseases such as infection, etc.
- Patients can't express himself clearly or with mental diseases;
- Tumor and other infectious diseases;
- With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
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 |
|---|---|---|
| acupunctureAlso: Acupuncture at Shumu acupointsacupuncture group1, acupoints ST25 and BL25 will be used in this trial. | Other | acupuncture group 1 |
| acupuncture group2Also: Acupuncture at He acupointsAcupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb. | Other | acupuncture group 2 |
| acupuncture group3Also: Acupuncture at Shumu and He acupointsAll acupoints used in acupuncture group1 and group2 will be used in this group. | Other | acupuncture group 3 |
| LoperamideAlso: LuopaidinganLoperamide will be used in this group for a dose of 2mg a time, three time a day. | Drug | Loperamide |
Primary outcome
Average weekly stool frequency
Time frame: 4th week after inclusion
Average weekly stool frequency, change from baseline in 4 weeks
3 secondary outcomes
Assessment score of Bristol stool scale
Time frame: 4th and 8th week after inclusion
Assessment score of SF-36 scale
Time frame: 4th and 8th after inclusion
Number of patients with adverse events after treatment
Time frame: 4th week after inclusion
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 10 Apr 2015.
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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.
Ying Li, MD, PhD principal investigator
Chengdu University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing acupuncture, acupuncture group2 and acupuncture group3 in people with Diarrhea-predominant Irritable Bowel Syndrome and Functional Diarrhea, run by Chengdu University of Traditional Chinese Medicine 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 4 inclusion and 4 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 10 Apr 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Average weekly stool frequency (time frame: 4th week after inclusion). 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 10 Apr 2015.