NCT01671670

Acupuncture for Patients With Function Dyspepsia

Phase III Study of Acupuncture for Patients With Functional Dyspepsia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia Design: * A single blind randomized controlled trial * 200 participants will be included * Two arms: acupuncture and sham acupuncture group

Detailed description

Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.

Conditions

• Functional Dyspepsia
• Postprandial Distress Syndrome

Interventions

Type	Name	Description
OTHER	acupuncture	In this group, acupuncture is given according to traditional acupuncture theories.
OTHER	sham acupuncture	Sham acupuncture points will be used in this trial, with needle penetration.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2012-08-23
• Last updated: 2014-12-02

Locations

1 site across 1 country: China