Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

NCT04980703 | Not Yet Recruiting DMC

• 1 other identifier: ZYS20210601
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

moxibustion; insomnia

Outcome Measures

Primary Outcomes (1)

• Changes of Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the changes of PSQI scores between baseline to week 4 as the primary outcome, to evaluate the effectiveness of acupuncture for depression related insomnia.

  Baseline and week 4

Secondary Outcomes (7)

• Changes of PSQI scores

  Baseline and week 12

• Sleep monitoring of bracelet

  Week 12

• Changes of Athens Insomnia Scale(AIS)

  Baseline and week 12

• Changes of Generalized Anxiety Disorder Scale-7(GAD-7)

  Baseline and week 12

• Changes of Patient Health Questionnaire-9 (PHQ-9)

  Baseline and week 12

Other Outcomes (2)

• Blind evaluation

  Week 4

• Abnormalities after the moxibustion

  Week 4

Study Arms (3)

Grain moxibustion

EXPERIMENTAL

Grain moxibustion +standard care

Device: Grain moxibustion

Sham grain moxibustion

SHAM COMPARATOR

Sham grain moxibustion +standard care

Device: Sham grain moxibustion

Wait-list control

OTHER

Standard care

Other: Standard care

Interventions

Grain moxibustion DEVICE

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.).

Grain moxibustion

Sham grain moxibustion DEVICE

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.).

Sham grain moxibustion

Standard care OTHER

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.

Wait-list control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Shanghai University of Traditional Chinese Medicine: collaborator

Study Sites (2)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Huangan Wu, PhD, MD

  Shanghai Institute of Acupuncture and Meridian

  STUDY CHAIR

Central Study Contacts

Chunhui Bao, PhD, MD

CONTACT

+8664395973; baochunhui789@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 28, 2021
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will be published online and is expected to be available in one to two years.
• Access Criteria: Open up online for everyone.

Locations

CN (2)