Clinical trial NCT01697761: 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
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
CAM
Keywords: Crohn's disease,acupuncture,moxibustion,inflammation factors
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CDAI
timeFrame: 2 years
Secondary outcomes:
measure: Inflammatory factors
timeFrame: 2 years
measure: Neurotransmitter
timeFrame: 2 years
measure: IBDQ
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture-Moxibustion and Merdian
state: Shanghai
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Wu Huangan, PhD
role: STUDY_CHAIR
References:
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.