Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn's Disease; CAM
• Interventions: Other: Treatment Group; Other: Control Group

• Registration Number: NCT01697761
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.

Detailed Description

The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.

Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2013-08
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• age 18-70 years;
• Crohn's Disease Activity Index [CDAI]>150 and <450;
• not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant;
• Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study
• signing a written informed consent form.

Exclusion Criteria

• Severe Crohn's disease patients or patients in remission ( CDAI > 450 or < 150 );
• The pregnancy or lactation period patients ;
• patients associated with heart, brain, liver, kidney and hematopoietic system disease;
• The psychiatric patients;
• Patients with other serious diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Treatment Group	treat by moxibustion and acupuncture
Control Group	Control Group	treat by Sham acupuncture and moxibustion

Primary Outcome Measures

Name	Time	Method
CDAI	2 years	Crohn's Disease Activity Index

Secondary Outcome Measures

Name	Time	Method
IBDQ	2 years	Inflammatory Bowel Disease Questionnaire
Inflammatory factors	2 years	Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc
Neurotransmitter	2 years	Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc

Trial Locations

Locations (1)

Shanghai Institute of Acupuncture-Moxibustion and Merdian; 🇨🇳 Shanghai, Shanghai, China