Crohn's Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | November 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Institute of Acupuncture-Moxibustion and Merdian | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Institute of Acupuncture, Moxibustion and Meridian |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CDAI | Crohn's Disease Activity Index | 2 years | No |
Secondary | Inflammatory factors | Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc | 2 years | Yes |
Secondary | Neurotransmitter | Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc | 2 years | Yes |
Secondary | IBDQ | Inflammatory Bowel Disease Questionnaire | 2 years | No |
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