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| ID | Type | Description | Link |
|---|---|---|---|
| 2012CB518501 | Other Grant/Funding Number | The Chinese Ministry of science and technology |
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| Name | Class |
|---|---|
| Hunan University of Traditional Chinese Medicine | OTHER |
| Chongqing Medical University | OTHER |
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Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia
Design:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental | use traditional acupuncture to treat functional dyspepsia |
|
| sham acupuncture group | Sham Comparator | use penetrating sham acupuncture to manage functional dyspepsia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | In this group, acupuncture is given according to traditional acupuncture theories. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants reporting complete absence of dyspeptic symptoms | at 16 weeks after inclusion |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fan-rong Liang, MD | Chengdu University of TCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu University of TCM | Chengdu | Sichuan | 610075 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22243034 | Background | 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. | |
| 23901030 |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Other | Sham acupuncture points will be used in this trial, with needle penetration. |
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| 4 weeks after inclusion |
| 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. |