Functional Dyspepsia, Postprandial Distress Syndrome
Conditions
Keywords
Functional dyspepsia, postprandial distress syndrome
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.
Interventions
OTHERacupuncture
In this group, acupuncture is given according to traditional acupuncture theories.
OTHERsham acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.
Sponsors
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants reporting complete absence of dyspeptic symptoms | at 16 weeks after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed