Functional Dyspepsia Clinical Trial
Official title:
Phase III Study of Acupuncture for Patients With Functional Dyspepsia
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
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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