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NOT YET RECRUITING
NCT04980703
NA

Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

View on ClinicalTrials.gov

Summary

This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2027-07-01

Completion Date

2029-07-31

Last Updated

2025-05-14

Healthy Volunteers

No

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.

Locations (2)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, China

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, China