Efficacy and Safety of Acupuncture for Functional Constipation

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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. .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Citric Acid; Mosapride; Sodium Citrate

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