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Functional Dyspepsia | Acupuncture for Patients With Function Dyspepsia

Functional Dyspepsia research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia

Postprandial Distress Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:acupunctureIn this group, acupuncture is given according to traditional acupuncture theories.

Other:sham acupunctureSham acupuncture points will be used in this trial, with needle penetration.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

acupuncture groupuse traditional acupuncture to treat functional dyspepsia

sham acupuncture groupuse penetrating sham acupuncture to manage functional dyspepsia

Study Status

Completed

Start Date: September 2012

Completed Date: November 2014

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: The proportion of participants reporting complete absence of dyspeptic symptoms

Secondary Outcome: validated Leeds Dyspepsia Questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Fan-rong Liang, MD

Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Collaborator: Hunan University of Traditional Chinese Medicine

More information:https://clinicaltrials.gov/show/NCT01671670

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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