Clinical trial NCT01671670: Acupuncture for Patients With Function Dyspepsia
Official title: Phase III Study of Acupuncture for Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Functional Dyspepsia
Postprandial Distress Syndrome
Keywords: Functional dyspepsia
postprandial distress syndrome
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Hunan University of Traditional Chinese Medicine
name: Chongqing Medical University
First posted: 2012-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of participants reporting complete absence of dyspeptic symptoms
timeFrame: at 16 weeks after inclusion
Secondary outcomes:
measure: validated Leeds Dyspepsia Questionnaire
timeFrame: 4, 8, 16, 20, 24 weeks after inclusion
measure: Nepean dyspepsia index
timeFrame: 4, 8, 16, 20, 24 weeks after inclusion
measure: adverse events in each group
timeFrame: 4 weeks after inclusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fan-rong Liang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Zheng H, Xu J, Li J, Li X, Zhao L, Chang X, Liu M, Gong B, Li X, Liang F. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial. BMJ Open. 2013 Jul 30;3(7):e003377. doi: 10.1136/bmjopen-2013-003377.