Not Yet RecruitingNot Applicable

Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

China102 participantsStarted 2027-07-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Meet the diagnostic criteria of insomnia;
✓. TCM syndrome differentiation belongs to deficiency of both heart and spleen;
✓. Male or female participants aged 18-75;
✓. Participants whose PSQI score is 5-15;
✓. The course of disease is more than 3 months;
✓. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Exclusion criteria

✕. Participants with mental retardation;
✕. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;
✕. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);
✕. Female participants who is pregnant or lactating;
✕. Participants with diabetes and sensory dysfunction.
✕. Participants with skin diseases of acupoints;
✕. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;
✕. Participants with dependence on sleeping drugs;

What they're measuring

Changes of Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Baseline and week 4

Trial details

NCT IDNCT04980703

SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-31

Contact for this trial

Chunhui Bao, PhD, MD

+8664395973 baochunhui789@126.com

View on ClinicalTrials.gov More Sleep Initiation and Maintenance Disorders trials