NCT01411501

Efficacy and Safety of Acupuncture for Functional Constipation

Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 684 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Constipation

Interventions

Type	Name	Description
OTHER	acupuncture	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.
DRUG	mosapride citrate	4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2011-08-08
• Last updated: 2015-12-11
• Results posted: 2015-12-11

Locations

1 site across 1 country: China