Efficacy and Safety of Acupuncture for Functional Constipation
1 other identifier
interventional
684
1 country
1
Brief 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. 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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedDecember 11, 2015
November 1, 2015
3.1 years
July 28, 2011
September 25, 2015
November 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of the SBMs From Baseline at Week 4
\[average number of spontaneous bowel movements in a week at week 4\]-\[average number of spontaneous bowel movements in a week at baseline\]
baseline and at 4 weeks
Secondary Outcomes (5)
Change From Baseline in the Bristol Stool Scale at the 4th Week
baseline and at 4 weeks
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
baseline and at 4 weeks
Changes of the SBMs From Baseline at Week 8
baseline and at 8 weeks
Change From Baseline in the Bristol Stool Scale at the 8th Week
baseline and at 8 weeks
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
baseline and at 8 weeks
Study Arms (4)
Acupuncture at ST25 and BL25
EXPERIMENTALthe points formula of back-shu point combination with front-mu point.
Acupuncture at LI11 and ST37
EXPERIMENTALthe points formula of He-points
Acupuncture at ST25, BL25, LI11 and ST37
EXPERIMENTALthe formula of He-point,back-shu point and front-mu point
medicine
ACTIVE COMPARATORoral use of mosapride citrate
Interventions
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.
4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
No.5 Beixiange Street, Xuanwu District
Beijing, 100053, China
Related Publications (1)
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.
PMID: 22759406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Unblinding of participants in the acupuncture and mosapride groups;an insufficient duration to assess the long term effect or risks;a missing assessment of electrocardiograms for possible cardiovascular harm of mosapride
Results Point of Contact
- Title
- Liu Zhishun
- Organization
- Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Study Officials
- STUDY CHAIR
LIU Zhishun, phD
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of Acupuncture Department of Guangan'men Hospital
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 8, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
December 11, 2015
Results First Posted
December 11, 2015
Record last verified: 2015-11