Acupuncture Treatment for Active Crohn's Disease
NCT02559037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2020-04-07
Summary
The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.
Conditions
Interventions
- DEVICE
-
Acupuncture and moxibustion
Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30\*40mm or 0.30\*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min. Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
- DEVICE
-
Sham acupuncture and moxibustion
The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 \* 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation. Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
Sponsors & Collaborators
-
Fudan University
collaborator OTHER -
Shanghai University of Traditional Chinese Medicine
collaborator OTHER -
Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Indiana University School of Medicine
collaborator OTHER -
Changhai Hospital
collaborator OTHER -
Shanghai Institute of Acupuncture, Moxibustion and Meridian
lead OTHER
Principal Investigators
-
Huangan Wu, MD,PhD · Shanghai University of TCM
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-04-01
- Primary Completion
- 2018-12-31
- Completion
- 2019-11-30
Countries
- China
Study Locations
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