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Electroacupuncture for the Treatment of Functional Constipation

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ClinicalTrials.gov Identifier: NCT01781897
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
Sponsor:
Information provided by (Responsible Party):
Guangying Huang, Huazhong University of Science and Technology

Study Description
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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

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.

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. number of defecation per week [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781897


Contacts
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Contact: Guangying Huang, Doctor 86-027-8366-3266 Gyhuang@tjh.tjmu.edu.cn

Locations
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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
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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
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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:
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