Acupuncture for Patients With Function Dyspepsia

Phase 2

Completed

• Conditions: Postprandial Distress Syndrome; Functional Dyspepsia
• Interventions: Other: acupuncture; Other: sham acupuncture

• Registration Number: NCT01671670
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-23
• Study Start: 2012-09
• Primary Completion: 2014-06
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture group	acupuncture	use traditional acupuncture to treat functional dyspepsia
sham acupuncture group	sham acupuncture	use penetrating sham acupuncture to manage functional dyspepsia

Primary Outcome Measures

Name	Time	Method
The proportion of participants reporting complete absence of dyspeptic symptoms	at 16 weeks after inclusion

Secondary Outcome Measures

Name	Time	Method
validated Leeds Dyspepsia Questionnaire	4, 8, 16, 20, 24 weeks after inclusion
Nepean dyspepsia index	4, 8, 16, 20, 24 weeks after inclusion
adverse events in each group	4 weeks after inclusion

Trial Locations

Locations (1)

Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China