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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01697761
Other study ID # SHACU-201202
Secondary ID
Status Completed
Phase N/A
First received September 28, 2012
Last updated November 19, 2014
Start date September 2012
Est. completion date November 2014

Study information

Verified date September 2012
Source Shanghai Institute of Acupuncture, Moxibustion and Meridian
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationChina: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Treatment Group
patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes,3 times a week for 12 weeks
Control Group
patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.

Locations

Country Name City State
China Shanghai Institute of Acupuncture-Moxibustion and Merdian Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

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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