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Electroacupuncture for the Treatment of Functional Constipation
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Guangying Huang, Huazhong University of Science and Technology.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Guangying Huang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01781897
First received: January 23, 2013
Last updated: March 17, 2015
Last verified: April 2014
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Purpose
The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.
| Condition | Intervention | Phase |
|---|---|---|
| Functional Constipation | Device: acupuncture Drug: mosapride | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation |
Resource links provided by NLM:
Further study details as provided by Guangying Huang, Huazhong University of Science and Technology:
Primary Outcome Measures:
- number of defecation per week [ Time Frame: 3 years ]
| Estimated Enrollment: | 243 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: mosapride
mosapride
|
Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Name: GASMOTIN
|
|
Experimental: Electro-acupuncture
Electro-acupuncture
|
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
|
|
Sham Comparator: mosapride + sham acupuncture
mosapride + sham acupuncture
|
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
|
Detailed Description:
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.
Eligibility| 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781897
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Guangying Huang, professor, Huazhong University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01781897 History of Changes |
| Other Study ID Numbers: |
2011CB505203-1 |
| Study First Received: | January 23, 2013 |
| Last Updated: | March 17, 2015 |
Keywords provided by Guangying Huang, Huazhong University of Science and Technology:
|
acupuncture electro-acupuncture |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on August 16, 2017