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

NCT01697761 | Completed DMC

• 1 other identifier: SHACU-201202
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; CAM

Keywords

Crohn's disease,acupuncture,moxibustion,inflammation factors

Outcome Measures

Primary Outcomes (1)

• CDAI

  Crohn's Disease Activity Index

  2 years

Secondary Outcomes (3)

• Inflammatory factors

  2 years

• Neurotransmitter

  2 years

• IBDQ

  2 years

Study Arms (2)

Treatment Group

EXPERIMENTAL

treat by moxibustion and acupuncture

Other: Treatment Group

Control Group

EXPERIMENTAL

treat by Sham acupuncture and moxibustion

Other: Control Group

Interventions

Treatment Group OTHER

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

Also known as: acupuncture and moxibustion group, acupuncture and Herbs-partitioned moxibustion group

Treatment Group

Control Group OTHER

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

Also known as: Sham acupuncture and moxibustion group

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• 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.

  PMID: 25152604 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Acupuncture Therapy; Control Groups

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wu Huangan, PhD

  Shanghai Institute of Acupuncture, Moxibustion and Meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2012-09

Locations

CN (1)