NCT02559037

Acupuncture Treatment for Active Crohn's Disease

Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. A randomized controlled trial. 2. Acupuncture and moxibustion treatment, placebo control. 3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease. 4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease. 5. To observe the effect on the regulation of peripheral immunity in Crohn's disease. 6. To observe the effect on the regulation of brain function and structure in Crohn's disease.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-31
• Completion: 2019-11-30
• First posted: 2015-09-24
• Last updated: 2020-04-07

Locations

1 site across 1 country: China