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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01274793
• Other study ID #: 2011CB505203
• Status: Recruiting
• Phase: Phase 1
• First received: January 11, 2011
• Last updated: March 17, 2015
• Start date: November 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Huazhong University of Science and Technology
• Contact: Guangying Huang, doctor
• Phone: 86-27-83663266
• Email: gyhuang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture with Two-ways Regulation Effect to Treat Functional Enteropathy

Description:

eligibility criteria: functional constipation,functional diarrhea，irritable bowel syndrome

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• function constipation function diarrhea

Exclusion Criteria:

• not function constipation not function diarrhea

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Diarrhea
• Functional Constipation
• Functional Diarrhea

Intervention

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.

Device:
• Low-dose acupuncture
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
• High-dose acupuncture
In this group,the current was strong enough to reach the patients'tolerance threshold value.

Locations

Country	Name	City	State
China	Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Guangzhou University of Traditional Chinese Medicine, The Fifth Hospital of Wuhan, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acupuncture benefits functional constipation		5 years	No