ConstipationPhase 3NCT01411501
Efficacy and Safety of Acupuncture for Functional Constipation
A Phase 3 study testing acupuncture and mosapride citrate in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- acupuncture and mosapride citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2014
- Phase
- Phase 3
- 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
- Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
- Patients who are aged 18-75 years old
- Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
- Sign the informed consent out of one's own will
Who cannot join
- Secondary constipation
- Patients with consciousness impairment, psychotic patients or patients unable to express clearly
- Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
- Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
- Women in pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .
Read the detailed description
functional constipation,acupuncture,effects and safety,pragmatic RCT
- Conditions
- Constipation
- Being tested
- acupuncture, mosapride citrate
- 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.
acupunctureOther
Also called acupuncture and moxibustion
Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.
mosapride citrateDrug
Also called mosapride citrate,made in China
4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture at ST25 and BL25 | Experimental | the points formula of back-shu point combination with front-mu point. Receives: Other: acupuncture |
| Acupuncture at LI11 and ST37 | Experimental | the points formula of He-points Receives: Other: acupuncture |
| Acupuncture at ST25, BL25, LI11 and ST37 | Experimental | the formula of He-point,back-shu point and front-mu point Receives: Other: acupuncture |
| medicine | Active comparator | oral use of mosapride citrate Receives: Drug: mosapride citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the SBMs From Baseline at Week 4
[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]
Measured: baseline and at 4 weeks
Secondary outcomes (5)
Change From Baseline in the Bristol Stool Scale at the 4th Week
Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.
Measured: baseline and at 4 weeks
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.
0-Without difficulty
- Defecation straining
- Severe defecation straining
- Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.
[the average score of one week at the 4th week]-[the average score of one week at baseline]
Measured: baseline and at 4 weeks
Changes of the SBMs From Baseline at Week 8
[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]
Measured: baseline and at 8 weeks
Change From Baseline in the Bristol Stool Scale at the 8th Week
Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.
Measured: baseline and at 8 weeks
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.
0-Without difficulty
- Defecation straining
- Severe defecation straining
- Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.
[the average score of one week at the 8th week]-[the average score of one week at baseline]
Measured: baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionDec 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 684 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
- LIU Zhishun, phD, Study chair, Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411501
- Sponsor's protocol ID
- 2011CB505202
- Status last verified
- Nov 2015
- First submitted
- 28 Jul 2011
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Li Y, Zheng H, Zeng F, Zhou SY, Zhong F, Zheng HB, Chen M, Jing XH, Cai YY, Jia BH, Zhu B, Liu ZS. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial. Trials. 2012 Jul 3;13:104. doi: 10.1186/1745-6215-13-104.
PubMed 22759406
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01411501
- Acronym / sponsor ID
- 2011CB505202
- Conditions
- Constipation
- Keywords
- Acupuncture, Functional constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 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
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .
Detailed description
functional constipation,acupuncture,effects and safety,pragmatic RCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupuncture at ST25 and BL25 | Experimental | Other: acupuncturethe points formula of back-shu point combination with front-mu point. |
| Acupuncture at LI11 and ST37 | Experimental | Other: acupuncturethe points formula of He-points |
| Acupuncture at ST25, BL25, LI11 and ST37 | Experimental | Other: acupuncturethe formula of He-point,back-shu point and front-mu point |
| medicine | Active comparator | Drug: mosapride citrateoral use of mosapride citrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
- Patients who are aged 18-75 years old
- Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
- Sign the informed consent out of one's own will
Key exclusion criteria (5 listed)
- Secondary constipation
- Patients with consciousness impairment, psychotic patients or patients unable to express clearly
- Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
- Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
- Women in pregnancy and lactation period
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 and moxibustionThrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | Other | Acupuncture at LI11 and ST37, Acupuncture at ST25 and BL25, Acupuncture at ST25, BL25, LI11 and ST37 |
| mosapride citrateAlso: mosapride citrate,made in China4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal | Drug | medicine |
Primary outcome
Change of the SBMs From Baseline at Week 4
Time frame: baseline and at 4 weeks
[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]
5 secondary outcomes
Change From Baseline in the Bristol Stool Scale at the 4th Week
Time frame: baseline and at 4 weeks
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
Time frame: baseline and at 4 weeks
Changes of the SBMs From Baseline at Week 8
Time frame: baseline and at 8 weeks
Change From Baseline in the Bristol Stool Scale at the 8th Week
Time frame: baseline and at 8 weeks
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
Time frame: baseline and at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22759406Li Y, Zheng H, Zeng F, Zhou SY, Zhong F, Zheng HB, Chen M, Jing XH, Cai YY, Jia BH, Zhu B, Liu ZS. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial. Trials. 2012 Jul 3;13:104. doi: 10.1186/1745-6215-13-104.
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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.
LIU Zhishun, phD study chair
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 3 study testing acupuncture and mosapride citrate 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 5 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 11 Dec 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 11 Dec 2015). 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 the SBMs From Baseline at Week 4 (time frame: baseline and at 4 weeks). 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 NCT01411501, 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 11 Dec 2015.