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Clinical Trial 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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01671670
Study type Interventional
Source Chengdu University of Traditional Chinese Medicine
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2012
Completion date November 2014

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