Electroacupuncture for the Treatment of Functional Constipation
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| ClinicalTrials.gov Identifier: NCT01781897 |
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Recruitment Status : Unknown
Verified April 2014 by Guangying Huang, Huazhong University of Science and Technology.
Recruitment status was: Recruiting
First Posted : February 1, 2013
Last Update Posted : March 19, 2015
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Sponsor:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Guangying Huang, Huazhong University of Science and Technology
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Brief Summary:
The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Functional Constipation | Device: acupuncture Drug: mosapride | Phase 1 |
This study will supply significant evidence for using acupuncture to treat functional constipation(FC), and will help us to identify whether it is a therapeutic effect rather than a placebo effect.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 243 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation |
| Study Start Date : | February 2013 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: mosapride
mosapride
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Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Name: GASMOTIN
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Experimental: Electro-acupuncture
Electro-acupuncture
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Device: acupuncture
sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
Other Name: Park true/sham devices
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Sham Comparator: mosapride + sham acupuncture
mosapride + sham acupuncture
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Device: acupuncture
sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
Other Name: Park true/sham devices
Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Name: GASMOTIN
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Primary Outcome Measures :
- number of defecation per week [ Time Frame: 3 years ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- functional constipation according to the Roman Ⅲ standard;
- aged between 18 and 65 years old
Exclusion criteria:
- unconsciousness, psychosis or can't express subjective symptoms;
- pregnant women or women in lactation period;
- serious diseases of the heart, liver, kidney, and others;
- bleeding disorders.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781897
Contacts
| Contact: Guangying Huang, Doctor | 86-027-8366-3266 | Gyhuang@tjh.tjmu.edu.cn |
Locations
| China, Hubei | |
| Hospital of Huazhong University of Science and Technology | Recruiting |
| Wuhan, Hubei, China, 430000 | |
| Contact: Jing Gui, Master +8615327285070 841946472@qq.com | |
| Principal Investigator: Jing Gui, Master | |
| Hubei Provincial Hospital of TCM | Recruiting |
| Wuhan, Hubei, China, 430000 | |
| Contact: Feng Hu, Doctor +8613469974981 351552735@qq.com | |
| Principal Investigator: Feng Hu, Doctor | |
| Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
| Wuhan, Hubei, China, 430030 | |
| Contact: Guangying Huang, doctor 86-027-8366-3266 Gyhuang@tjh.tjmu.edu.cn | |
| Principal Investigator: Mingmin Zhang, Doctor | |
| Principal Investigator: Cuihong Zheng, Doctor | |
| Principal Investigator: Xiaohu Xu, Doctor | |
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
| Principal Investigator: | Xiaohu Xu, Doctor | HUST(Huazhong University of Science and Technology) Hospital | |
| Principal Investigator: | Feng Hu, Master | Hubei Hospital of Traditional Chinese Medicine |
| Responsible Party: | Guangying Huang, professor, Huazhong University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01781897 History of Changes |
| Other Study ID Numbers: |
2011CB505203-1 |
| First Posted: | February 1, 2013 Key Record Dates |
| Last Update Posted: | March 19, 2015 |
| Last Verified: | April 2014 |
Keywords provided by Guangying Huang, Huazhong University of Science and Technology:
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acupuncture electro-acupuncture |
Additional relevant MeSH terms:
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Constipation Signs and Symptoms, Digestive Signs and Symptoms Mosapride Gastrointestinal Agents |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |