Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 1, 2027

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2029

Conditions
Sleep Initiation and Maintenance Disorders
Interventions
DEVICE

Grain moxibustion

Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the patient feels burning or a little pain, put out moxa with gauze and keep for 10 seconds, so as to ensure enough heat to be penetrated into the acupoint. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).

DEVICE

Sham grain moxibustion

Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the moxa burns to half (the patient hasn't feel hot or feel a little hot), take the moxa away with tweezers. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).

OTHER

Standard care

Participants in the wait-list control with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.). And after waiting for 12 weeks, these patients will be treated with the same grain moxibustion as the grain moxibustion group.

Trial Locations (2)

200030

Shanghai Institute of Acupuncture, Moxibustion and Meridian, Shanghai

Unknown

Shanghai Institute of Acupuncture, Moxibustion and Meridian, Shanghai

All Listed Sponsors
collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

lead

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER