Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
The Fifth Hospital of Wuhan
Wuhan Union Hospital, China
Guangzhou University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Guangying Huang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01274793
First received: January 11, 2011
Last updated: March 17, 2015
Last verified: March 2015
  Purpose
the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture with Two-ways Regulation Effect to Treat Functional Enteropathy

Condition Intervention Phase
Functional Constipation
Functional Diarrhea
Drug: Mosapride Citrate tablet
Device: Low-dose acupuncture
Device: High-dose acupuncture
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Randomized Controlled Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • acupuncture benefits functional constipation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2010
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
In the control group were orally administered 5 mg mosapride citrate tablet s three times a day for 4 continu ous weeks if no severe adverse effects were found.
Drug: Mosapride Citrate tablet
Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.
Other Name: GASMOTIN
Experimental: Low-dose acupuncture
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Device: Low-dose acupuncture
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Experimental: High-dose acupuncture
In this group,the current was strong enough to reach the patients'tolerance threshold value.
Device: High-dose acupuncture
In this group,the current was strong enough to reach the patients'tolerance threshold value.

Detailed Description:
eligibility criteria: functional constipation,functional diarrhea,irritable bowel syndrome
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • function constipation function diarrhea

Exclusion Criteria:

  • not function constipation not function diarrhea
  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: NCT01274793

Contacts
Contact: Guangying Huang, doctor 86-27-83663266 gyhuang@tjh.tjmu.edu.cn

Locations
China, Hubei
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: Fan Xiong, Doctor         
Principal Investigator: Ying Wang, Master         
Principal Investigator: Man Tian, Master         
Sponsors and Collaborators
Huazhong University of Science and Technology
The Fifth Hospital of Wuhan
Wuhan Union Hospital, China
Guangzhou University of Traditional Chinese Medicine
Investigators
Study Director: Guangying Huang, doctor institute of integrated traditional chinese and western medicine,Tongji meidical college,HUST
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guangying Huang, Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01274793     History of Changes
Other Study ID Numbers: 2011CB505203 
Study First Received: January 11, 2011
Last Updated: March 17, 2015
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
functional constipation
functional diarrhea
acupuncture

Additional relevant MeSH terms:
Constipation
Diarrhea
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Citric Acid
Mosapride
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016