Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2012-09-30
2014-11-30
Brief Summary
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Design:
* A single blind randomized controlled trial
* 200 participants will be included
* Two arms: acupuncture and sham acupuncture group
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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acupuncture group
use traditional acupuncture to treat functional dyspepsia
acupuncture
In this group, acupuncture is given according to traditional acupuncture theories.
sham acupuncture group
use penetrating sham acupuncture to manage functional dyspepsia
sham acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.
Interventions
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acupuncture
In this group, acupuncture is given according to traditional acupuncture theories.
sham acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Hunan University of Traditional Chinese Medicine
OTHER
Chongqing Medical University
OTHER
Chengdu University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Fan-rong Liang, MD
Role: STUDY_CHAIR
Chengdu University of TCM
Locations
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Chengdu University of TCM
Chengdu, Sichuan, China
Countries
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References
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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.
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.
Other Identifiers
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2012CB518501
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2012CB518501-3
Identifier Type: -
Identifier Source: org_study_id