Acupuncture for Patients With Function Dyspepsia

Chengdu University of Traditional Chinese Medicine200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Functional Dyspepsia Postprandial Distress Syndrome

Interventions

acupunctureOTHER

In this group, acupuncture is given according to traditional acupuncture theories.

sham acupunctureOTHER

Sham acupuncture points will be used in this trial, with needle penetration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Consistent with the diagnostic criteria of functional dyspepsia. * Age of a subject is older than 18 and is younger than 65.（including 18 and 65） * Include postprandial distress syndrome. * Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial. * Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: * Patients with any contraindications of Itopride. * Patients who are unconscious, psychotic. * Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding. * With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on. * Pregnant women or women in lactation.

Locations (1)

Chengdu University of TCM

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

The proportion of participants reporting complete absence of dyspeptic symptoms

Time frame: at 16 weeks after inclusion

Secondary Outcomes

validated Leeds Dyspepsia Questionnaire

Time frame: 4, 8, 16, 20, 24 weeks after inclusion

Nepean dyspepsia index

Time frame: 4, 8, 16, 20, 24 weeks after inclusion

adverse events in each group

Time frame: 4 weeks after inclusion

Data from ClinicalTrials.gov

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