Efficacy and Safety of Acupuncture for Functional Constipation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Constipation

Treatments: Drug: mosapride citrate; Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01411501

2011CB505202

Details and patient eligibility

About

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. .

Full description

functional constipation,acupuncture,effects and safety,pragmatic RCT

Enrollment: 684 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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684 participants in 4 patient groups

Acupuncture at ST25 and BL25

Experimental group

Description:

the points formula of back-shu point combination with front-mu point.

Treatment:

Other: acupuncture

Acupuncture at LI11 and ST37

Experimental group

Description:

the points formula of He-points

Treatment:

Other: acupuncture

Acupuncture at ST25, BL25, LI11 and ST37

Experimental group

Description:

the formula of He-point,back-shu point and front-mu point

Treatment:

Other: acupuncture

medicine

Active Comparator group

Description:

oral use of mosapride citrate

Treatment:

Drug: mosapride citrate