Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease
This study is enrolling participants by invitation only.
Sponsor:
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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
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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:
|
|
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
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 May 23, 2013