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Completed

NCT Number: NCT01697761

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treatment group

Other

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

Other names: acupuncture and moxibustion group, acupuncture and Herbs-partitioned moxibustion group

Control Group

Other

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

Other names: Sham acupuncture and moxibustion group

Primary outcomes

  1. CDAI

    Time frame: 2 years

    Crohn's Disease Activity Index

Secondary outcomes

  1. Inflammatory factors

    Time frame: 2 years

    Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc

  2. Neurotransmitter

    Time frame: 2 years

    Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc

  3. IBDQ

    Time frame: 2 years

    Inflammatory Bowel Disease Questionnaire

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 2, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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