ConstipationPhase 2NCT00508482
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
A Phase 2 study testing deep needling, Lactulose and shallow needling in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- deep needling, Lactulose and shallow needling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- meeting the diagnosis of Rome III criteria;
- aged from 18 to 75 years old;
- no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
- volunteered to join this trial and signed the informed consent form
Who cannot join
- irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- women in gestation or lactation period;
- abdominal aortic aneurysm or hepatosplenomegaly, etc.;
- blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
- cardiac pacemaker carrier.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.
Read the detailed description
Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment.
Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.
- Conditions
- Constipation
- Being tested
- deep needling, Lactulose, shallow needling
- Keywords
- Acupuncture, Functional constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep needlingOther
Also called acupuncture, electroacupuncture
Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain.
Once a day, five times a week, four weeks.
LactuloseDrug
Also called Lactulose produced by Solvay Pharmaceuticals BV
20-30ml, once a day before breakfast, for the whole study except the run-in period
shallow needlingOther
Also called acupuncture, electroacupuncture
Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
| Study group | Role | What they receive |
|---|---|---|
| deep needling group | Experimental | Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location, were used. After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 20~60mm until piercing into the muscle layer. Paired alligator clips of the electric acupuncture (EA) apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose. Patients were treated once a day, five times a week for continuous 4 weeks. Receives: Other: deep needling |
| lactulose group | Active comparator | Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed. Receives: Drug: Lactulose |
| shallow needling group | Active comparator | Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group. Receives: Other: shallow needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean Weekly Spontaneous Bowel Movements
Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.
Measured: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up
Secondary outcomes (9)
Change of Mean Value of Straining During Defecating
Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.
Measured: over 4 weeks of treatment
Change of Mean Value of Incomplete Evacuation
Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.
Measured: over 4 weeks of treatment
Change of Mean Value of Stool Consistency
Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.
Measured: over 4 weeks of treatment
Change of Mean Value of Abdominal Distention
Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.
Measured: over 4 weeks of treatment
Change of Mean Value of Cleveland Clinic Score
Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.
Measured: over 4 weeks of treatment
Time to the First Spontaneous Bowel Movement After the First Treatment
Measured: counting by hours
Percentage of the Usage of Emergency Drugs
Measured: over 4 weeks of treatment
Percentage of the Usage of Emergency Drugs
Measured: at the 4th week of follow-up
Percentage of the Usage of Emergency Drugs
Measured: at the 12th week of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startApr 2008
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, M.D., Study director, Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508482
- Sponsor's protocol ID
- 2006BAI12B05-1
- Status last verified
- May 2014
- First submitted
- 26 Jul 2007
- Last updated
- 4 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wu J, Liu B, Li N, Sun J, Wang L, Wang L, Cai Y, Ye Y, Liu J, Wang Y, Liu Z. Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial. Medicine (Baltimore). 2014 Dec;93(28):e284. doi: 10.1097/MD.0000000000000284.
PubMed 25526462
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
- ClinicalTrials.gov ID
- NCT00508482
- Acronym / sponsor ID
- 2006BAI12B05-1
- Conditions
- Constipation
- Keywords
- Acupuncture, Functional constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Apr 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Posted 15 Mar 2013
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 re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.
Detailed description
Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment.
Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| deep needling group | Experimental | Other: deep needlingAcupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location, were used. After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 20~60mm until piercing into the muscle layer. Paired alligator clips of the electric acupuncture (EA) apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose. Patients were treated once a day, five times a week for continuous 4 weeks. |
| lactulose group | Active comparator | Drug: LactuloseLactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed. |
| shallow needling group | Active comparator | Other: shallow needlingBilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meeting the diagnosis of Rome III criteria;
- aged from 18 to 75 years old;
- no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
- volunteered to join this trial and signed the informed consent form
Key exclusion criteria (6 listed)
- irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- women in gestation or lactation period;
- abdominal aortic aneurysm or hepatosplenomegaly, etc.;
- blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
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 |
|---|---|---|
| deep needlingAlso: acupuncture, electroacupunctureHuatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain. Once a day, five times a week, four weeks. | Other | deep needling group |
| LactuloseAlso: Lactulose produced by Solvay Pharmaceuticals BV20-30ml, once a day before breakfast, for the whole study except the run-in period | Drug | lactulose group |
| shallow needlingAlso: acupuncture, electroacupunctureHuatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group. | Other | shallow needling group |
Primary outcome
Change of Mean Weekly Spontaneous Bowel Movements
Time frame: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up
Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.
9 secondary outcomes
Change of Mean Value of Straining During Defecating
Time frame: over 4 weeks of treatment
Change of Mean Value of Incomplete Evacuation
Time frame: over 4 weeks of treatment
Change of Mean Value of Stool Consistency
Time frame: over 4 weeks of treatment
Change of Mean Value of Abdominal Distention
Time frame: over 4 weeks of treatment
Change of Mean Value of Cleveland Clinic Score
Time frame: over 4 weeks of treatment
Time to the First Spontaneous Bowel Movement After the First Treatment
Time frame: counting by hours
Percentage of the Usage of Emergency Drugs
Time frame: over 4 weeks of treatment
Percentage of the Usage of Emergency Drugs
Time frame: at the 4th week of follow-up
Percentage of the Usage of Emergency Drugs
Time frame: at the 12th week of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25526462Wu J, Liu B, Li N, Sun J, Wang L, Wang L, Cai Y, Ye Y, Liu J, Wang Y, Liu Z. Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial. Medicine (Baltimore). 2014 Dec;93(28):e284. doi: 10.1097/MD.0000000000000284.
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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.
Zhishun Liu, M.D. study director
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
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 deep needling, Lactulose and shallow needling in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 6 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 4 Jun 2014. 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 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?
Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Mean Weekly Spontaneous Bowel Movements (time frame: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508482, which also lists 1 linked publication.
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 4 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.