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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; CAM
• Intervention / Treatment: Other: Treatment Group; Other: Control Group

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Institute of Acupuncture-Moxibustion and Merdian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; treat by moxibustion and acupuncture	Other: Treatment Group; patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks; Other Names: acupuncture and moxibustion group; acupuncture and Herbs-partitioned moxibustion group
Experimental: Control Group; treat by Sham acupuncture and moxibustion	Other: Control Group; patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.; Other Names: Sham acupuncture and moxibustion group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDAI	Crohn's Disease Activity Index	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Investigators: Study Chair: Wu Huangan, PhD, Shanghai Institute of Acupuncture, Moxibustion and Meridian

Publications and helpful links

General Publications

• Bao CH, Zhao JM, Liu HR, Lu Y, Zhu YF, Shi Y, Weng ZJ, Feng H, Guan X, Li J, Chen WF, Wu LY, Jin XM, Dou CZ, Wu HG. Randomized controlled trial: moxibustion and acupuncture for the treatment of Crohn's disease. World J Gastroenterol. 2014 Aug 21;20(31):11000-11. doi: 10.3748/wjg.v20.i31.11000.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Crohn's disease,acupuncture,moxibustion,inflammation factors
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: SHACU-201202