Acupuncture for Patients With Function Dyspepsia

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

Full Title of Study: “Phase III Study of Acupuncture for Patients With Functional Dyspepsia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2014

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: acupuncture group
    • use traditional acupuncture to treat functional dyspepsia
  • Sham Comparator: sham acupuncture group
    • use penetrating sham acupuncture to manage functional dyspepsia

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of participants reporting complete absence of dyspeptic symptoms
    • Time Frame: at 16 weeks after inclusion

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chengdu University of Traditional Chinese Medicine
  • Collaborator
    • Hunan University of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fan-rong Liang, MD, Study Chair, Chengdu University of TCM

References

Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.

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