Electroacupuncture for the Treatment of Functional Constipation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2014 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
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 Huazhong University of Science and Technology:

Primary Outcome Measures:
  • number of defecation per week [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: China: Ethics Committee

Keywords provided by 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 July 24, 2016