- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01671670
Acupuncture for Patients With Function Dyspepsia
November 25, 2014 updated by: Chengdu University of Traditional Chinese Medicine
Phase III Study of Acupuncture for Patients With Functional 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
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610075
- Chengdu University of TCM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: acupuncture group
use traditional acupuncture to treat functional dyspepsia
|
In this group, acupuncture is given according to traditional acupuncture theories.
Other Names:
|
SHAM_COMPARATOR: sham acupuncture group
use penetrating sham acupuncture to manage functional dyspepsia
|
Sham acupuncture points will be used in this trial, with needle penetration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of participants reporting complete absence of dyspeptic symptoms
Time Frame: at 16 weeks after inclusion
|
at 16 weeks after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
validated Leeds Dyspepsia Questionnaire
Time Frame: 4, 8, 16, 20, 24 weeks after inclusion
|
4, 8, 16, 20, 24 weeks after inclusion
|
Nepean dyspepsia index
Time Frame: 4, 8, 16, 20, 24 weeks after inclusion
|
4, 8, 16, 20, 24 weeks after inclusion
|
adverse events in each group
Time Frame: 4 weeks after inclusion
|
4 weeks after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Fan-rong Liang, MD, Chengdu University of TCM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
August 21, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (ESTIMATE)
August 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 25, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012CB518501-3
- 2012CB518501 (OTHER_GRANT: The Chinese Ministry of science and technology)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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