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

Primary Purpose

Crohn's Disease, CAM

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Treatment Group
Control Group
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease,acupuncture,moxibustion,inflammation factors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Institute of Acupuncture-Moxibustion and Merdian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Group

Control Group

Arm Description

treat by moxibustion and acupuncture

treat by Sham acupuncture and moxibustion

Outcomes

Primary Outcome Measures

CDAI
Crohn's Disease Activity Index

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2012
Last Updated
November 19, 2014
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT01697761
Brief Title
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, CAM
Keywords
Crohn's disease,acupuncture,moxibustion,inflammation factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
treat by moxibustion and acupuncture
Arm Title
Control Group
Arm Type
Experimental
Arm Description
treat by Sham acupuncture and moxibustion
Intervention Type
Other
Intervention Name(s)
Treatment Group
Other Intervention Name(s)
acupuncture and moxibustion group, acupuncture and Herbs-partitioned moxibustion group
Intervention Description
patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Sham acupuncture and moxibustion group
Intervention Description
patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.
Primary Outcome Measure Information:
Title
CDAI
Description
Crohn's Disease Activity Index
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Inflammatory factors
Description
Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc
Time Frame
2 years
Title
Neurotransmitter
Description
Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc
Time Frame
2 years
Title
IBDQ
Description
Inflammatory Bowel Disease Questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Huangan, PhD
Organizational Affiliation
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Institute of Acupuncture-Moxibustion and Merdian
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25152604
Citation
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.
Results Reference
derived

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

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