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

NCT ID: NCT01697761

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

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.

Conditions

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Crohn's Disease CAM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment Group

treat by moxibustion and acupuncture

Group Type EXPERIMENTAL

Treatment Group

Intervention Type OTHER

patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes,3 times a week for 12 weeks

Control Group

treat by Sham acupuncture and moxibustion

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.

Interventions

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Treatment Group

patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes,3 times a week for 12 weeks

Intervention Type OTHER

Control Group

patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.

Intervention Type OTHER

Other Intervention Names

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acupuncture and moxibustion group acupuncture and Herbs-partitioned moxibustion group Sham acupuncture and moxibustion group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wu Huangan, PhD

Role: STUDY_CHAIR

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Locations

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Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 25152604 (View on PubMed)

Other Identifiers

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SHACU-201202

Identifier Type: -

Identifier Source: org_study_id