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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier:
NCT01697761
First received: September 28, 2012
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Crohn's Disease
CAM
Other: Treatment Group
Other: Control Group

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

Resource links provided by NLM:


Further study details as provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:

Primary Outcome Measures:
  • CDAI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Crohn's Disease Activity Index


Secondary Outcome Measures:
  • Inflammatory factors [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc

  • Neurotransmitter [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc

  • IBDQ [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sham acupuncture and moxibustion 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697761

Locations
China, Shanghai
Shanghai Institute of Acupuncture-Moxibustion and Merdian
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
Study Chair: Wu Huangan, PhD Shanghai Institute of Acupuncture, Moxibustion and Meridian
  More Information

No publications provided

Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT01697761     History of Changes
Other Study ID Numbers: SHACU-201202
Study First Received: September 28, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration
China: Ethics Committee

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
Crohn's disease,acupuncture,moxibustion,inflammation factors

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014