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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn's Disease, CAM

Intervention / Treatment
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* Other: Treatment Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease,acupuncture,moxibustion,inflammation factors