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

Crohn's Disease Clinical Trial

Official title:

Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697761
• Other study ID #: SHACU-201202
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: November 19, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2012
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CAM
• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Treatment Group
patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes,3 times a week for 12 weeks
• Control Group
patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.

Locations

Country	Name	City	State
China	Shanghai Institute of Acupuncture-Moxibustion and Merdian	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDAI	Crohn's Disease Activity Index	2 years	No
Secondary	Inflammatory factors	Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc	2 years	Yes
Secondary	Neurotransmitter	Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc	2 years	Yes
Secondary	IBDQ	Inflammatory Bowel Disease Questionnaire	2 years	No