Sleep Initiation and Maintenance DisordersNCT04980703
Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
A study testing Grain moxibustion in people with Sleep Initiation and Maintenance Disorders, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Grain moxibustion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2027to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality, 200030
Chunhui Bao, PhD,MD, 862164395973, baochunhui789@126.com
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality
Chunhui Bao, PhD,MD, 862164395973, baochunhui789@126.com
About this study
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.
Read the detailed description
Insomnia is one of the most common sleep disorders. The main symptoms are difficulty in falling asleep, decreased sleep quality and sleep time, and affect the normal work, study and life during the day.
Acupuncture has a good clinical effect on insomnia, but most of the treatment methods are acupuncture or electroacupuncture. Moxibustion therapy, as one of the main components of the therapy, has the advantages of simple operation, wide acceptance, which is suitable for a wide range of promotion and application.At present, the trials of moxibustion in the treatment of insomnia mainly focus on mild moxibustion. The number of studies is small, and the research is designed insufficiently, so it is difficult to draw a positive conclusion, and needs to be further confirmed by rigorous designed experiments. In addition, grain moxibustion, which is widely used in clinic, has the advantages of more convenient operation, short treatment time and strong permeability. However, its efficacy and safety in the treatment of insomnia are still unclear, so it is necessary to carry out a randomized controlled trial to confirm it.
One hundred and two eligible patients will be randomly assigned to one of 3 groups: grain moxibustion group, sham grain moxibustion group and wait-list control group. Treatment will be given 3 times per week for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are changes of PSQI scores from baseline to 8 week follow-up, sleep monitoring of bracelet, Athens Insomnia Scale（AIS）, Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9) and recurrence observation during the follow-up period. Daily dose of patients' estazolam will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment, as well as at 8 week and 12 week follow-up.
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, which will provide an experimental basis for the treatment of insomnia with grain moxibustion and lay the foundation for the promotion and application of moxibustion in the future.
- Being tested
- Grain moxibustion, Sham grain moxibustion, Standard care
- Keywords
- moxibustion, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grain moxibustionDevice
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 moxibustionDevice
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Grain moxibustion | Experimental | Grain moxibustion +standard care Receives: Device: Grain moxibustion |
| Sham grain moxibustion | Sham comparator | Sham grain moxibustion +standard care Receives: Device: Sham grain moxibustion |
| Wait-list control | Other | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (7)
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.
Measured: Baseline and week 12
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.
Measured: Week 12
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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 12
Changes of Patient Health Questionnaire-9 (PHQ-9)
Changes in depressive symptoms will be measured using the 9-item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0 to 27, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 has factorial validity for the diagnosis of major depressive disorder. The changes of PHQ-9 scores between baseline to week 4, week 8 and week 12 are the secondary outcome.
Measured: Baseline and week 12
Recurrence observation during the follow-up period
In case of relapse (PSQI score increase rate > 50% or need to adjust drugs to control the disease) or serious adverse reactions during the follow-up period, the time from the beginning to the end of treatment , the specific medication plan and the state of illness during the follow-up period will be recorded. The recurrence rate and average recurrence time during the follow-up period will be calculated according to the number of recurrence within week 4 to week 12 follow-up in each group.
Measured: Week 12
Dose dairy
Compare the use rate and dosage of estazolam during treatment and follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2027 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, PhD, MD, Study chair, Shanghai Institute of Acupuncture and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980703
- Sponsor's protocol ID
- ZYS20210601
- Status last verified
- May 2025
- First submitted
- 28 Jun 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be maintained by the principal investigator. Other investigators may consult with the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04980703
- Acronym / sponsor ID
- ZYS20210601
- Keywords
- moxibustion, insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insomnia is one of the most common sleep disorders. The main symptoms are difficulty in falling asleep, decreased sleep quality and sleep time, and affect the normal work, study and life during the day.
Acupuncture has a good clinical effect on insomnia, but most of the treatment methods are acupuncture or electroacupuncture. Moxibustion therapy, as one of the main components of the therapy, has the advantages of simple operation, wide acceptance, which is suitable for a wide range of promotion and application.At present, the trials of moxibustion in the treatment of insomnia mainly focus on mild moxibustion. The number of studies is small, and the research is designed insufficiently, so it is difficult to draw a positive conclusion, and needs to be further confirmed by rigorous designed experiments. In addition, grain moxibustion, which is widely used in clinic, has the advantages of more convenient operation, short treatment time and strong permeability. However, its efficacy and safety in the treatment of insomnia are still unclear, so it is necessary to carry out a randomized controlled trial to confirm it.
One hundred and two eligible patients will be randomly assigned to one of 3 groups: grain moxibustion group, sham grain moxibustion group and wait-list control group. Treatment will be given 3 times per week for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are changes of PSQI scores from baseline to 8 week follow-up, sleep monitoring of bracelet, Athens Insomnia Scale（AIS）, Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9) and recurrence observation during the follow-up period. Daily dose of patients' estazolam will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment, as well as at 8 week and 12 week follow-up.
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, which will provide an experimental basis for the treatment of insomnia with grain moxibustion and lay the foundation for the promotion and application of moxibustion in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grain moxibustion | Experimental | Device: Grain moxibustionGrain moxibustion +standard care |
| Sham grain moxibustion | Sham comparator | Device: Sham grain moxibustionSham grain moxibustion +standard care |
| Wait-list control | Other | Other: Standard careStandard care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grain moxibustionTake 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 | Grain moxibustion |
| Sham grain moxibustionTake 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.). | Device | Sham grain moxibustion |
| Standard careParticipants 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. | Other | Wait-list control |
Primary outcome
Changes of Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and week 4
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.
7 secondary outcomes
Changes of PSQI scores
Time frame: Baseline and week 12
Sleep monitoring of bracelet
Time frame: Week 12
Changes of Athens Insomnia Scale(AIS)
Time frame: Baseline and week 12
Changes of Generalized Anxiety Disorder Scale-7(GAD-7)
Time frame: Baseline and week 12
Changes of Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and week 12
Recurrence observation during the follow-up period
Time frame: Week 12
Dose dairy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be maintained by the principal investigator. Other investigators may consult with the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huangan Wu, PhD, MD study chair
Shanghai Institute of Acupuncture and Meridian
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grain moxibustion in people with Sleep Initiation and Maintenance Disorders, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunhui Bao, PhD, MD (+8664395973, baochunhui789@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.