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Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

ConditionSleep Initiation and Maintenance Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.).

  • 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.).

  • Standard care

    Other intervention

    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.

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: Grain moxibustionExperimental treatment 1 intervention
Group B: Sham grain moxibustionSham comparator 1 intervention
Group C: Wait-list controlOther 1 intervention

Trial outcomes

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.

Time frame
Baseline and week 4

Secondary outcomes

1

Changes of PSQI scores

As is mentioned above, PSQI is a widely-used questionnaire to assess one's sleep disorders over one month. In order to assess the effects of acupuncture on patients' sleep quality during the intervention period, and to assess the durative effects of acupuncture after the intervention ends, the investigators set the changes of PSQI scores between baseline to week 8 and week 12 as the secondary outcome.

Time frame
Baseline and week 12
2

Sleep monitoring of bracelet

Xiaomi Bracelet 3(XMSH05HM)will be worn on the wrist of the participants, recording the sleep time at night, deep sleep time, light sleep time, awake time, time to fall asleep last night and time to wake up this morning.

Time frame
Week 12
3

Changes of Athens Insomnia Scale(AIS)

Using the Athens Insomnia Scale to test the subjective sleep quality of patients. It is comprised of 8 items. The range were from 0-3. Total score \< 4 means sleep well; total score =4-6 means suspicious of insomnia; total score \> 6 means insomnia. The changes of AIS scores between baseline to week 4, week 8 and week 12 are the secondary outcome.

Time frame
Baseline and week 12
4

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

Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs for mild, moderate, and severe anxiety, respectively. An add-on item assessing the patient's global impression of symptom-related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is sensitive to change. The changes of GAD-7 scores between baseline to week 4, week 8 and week 12 are the secondary outcome.

Time frame
Baseline and week 12

Other outcomes

1

Blind evaluation

The participants will be asked to predict whether they were treated by grain moxibustion or sham grain moxibustion according to their self feelings.

Time frame
Week 4
2

Abnormalities after the moxibustion

Abnormalities after the moxibustion are skin scald, blistering or other discomfort caused by the moxibustion. Doctors will always have a burn ointment to prevent burns. If the patient gets a blister, the doctor will deal with it in time and inform the patient of the follow-up protective measures.

Time frame
Week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

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