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Completed

NCT Number: NCT01671670

Acupuncture for Patients With Function 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

Completed

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Key information

Conditions

Functional Dyspepsia Postprandial Distress Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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

Other names: use hwato acupuncture needles

Sham Acupuncture

Other

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

Other names: verum acupuncture

Primary outcomes

  1. The proportion of participants reporting complete absence of dyspeptic symptoms

    Time frame: at 16 weeks after inclusion

Secondary outcomes

  1. validated Leeds Dyspepsia Questionnaire

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

  2. Nepean dyspepsia index

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

  3. adverse events in each group

    Time frame: 4 weeks after inclusion

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Chongqing Medical University
  • Hunan University of Traditional Chinese Medicine

Registry information

Official study title

Phase III Study of Acupuncture for Patients With Functional Dyspepsia

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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