Clinical trial NCT01411501: Efficacy and Safety of Acupuncture for Functional Constipation
Official title: Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: Acupuncture
Functional constipation
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2011-08-08
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .

Detailed description: functional constipation,acupuncture,effects and safety,pragmatic RCT

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of the SBMs From Baseline at Week 4
timeFrame: baseline and at 4 weeks
Secondary outcomes:
measure: Change From Baseline in the Bristol Stool Scale at the 4th Week
timeFrame: baseline and at 4 weeks
measure: Change From Baseline in Difficulty Degree of Defecation at the 4th Week
timeFrame: baseline and at 4 weeks
measure: Changes of the SBMs From Baseline at Week 8
timeFrame: baseline and at 8 weeks
measure: Change From Baseline in the Bristol Stool Scale at the 8th Week
timeFrame: baseline and at 8 weeks
measure: Change From Baseline in Difficulty Degree of Defecation at the 8th Week
timeFrame: baseline and at 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.5 Beixiange Street, Xuanwu District
Study officials:
affiliation: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
name: LIU Zhishun, phD
role: STUDY_CHAIR
References:
citation: 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.