66
Participants
Start Date
April 1, 2015
Primary Completion Date
December 31, 2018
Study Completion Date
November 30, 2019
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."
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."
Shanghai Institute of Acupuncture, Moxibustion and Meridian, Shanghai
Fudan University
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Indiana University School of Medicine
OTHER
Changhai Hospital
OTHER
Shanghai Institute of Acupuncture, Moxibustion and Meridian
OTHER