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Electroacupuncture for the Treatment of Functional Constipation

This study is not yet open for participant recruitment.
Verified January 2013 by Huazhong University of Science and Technology
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: January 31, 2013
Last verified: January 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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: 280
Study Start Date: February 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mosapride
mosapride
 Drug: mosapride
Experimental: low-dose acupuncture
low-dose acupuncture
 Device: acupuncture
Experimental: high-dose acupuncture
high-dose acupuncture
 Device: acupuncture
Sham Comparator: mosapride + sham acupuncture
mosapride + sham acupuncture
 Device: acupuncture Drug: mosapride

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
No Contacts or Locations Provided
  More Information

No publications provided

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: January 31, 2013
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
Serotonin Receptor Agonists
Serotonin Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013