Clinical trial NCT04980703: Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
Official title: Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: moxibustion
insomnia
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
First posted: 2021-07-28
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Participants with mental retardation;
2. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;
3. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);
4. Female participants who is pregnant or lactating;
5. Participants with diabetes and sensory dysfunction.
6. Participants with skin diseases of acupoints;
7. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;
8. Participants with dependence on sleeping drugs;
9. Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.

Primary outcomes:
measure: Changes of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Changes of PSQI scores
timeFrame: Baseline and week 12
measure: Sleep monitoring of bracelet
timeFrame: Week 12
measure: Changes of Athens Insomnia Scale(AIS)
timeFrame: Baseline and week 12
measure: Changes of Generalized Anxiety Disorder Scale-7(GAD-7)
timeFrame: Baseline and week 12
measure: Changes of Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and week 12
measure: Recurrence observation during the follow-up period
timeFrame: Week 12
measure: Dose dairy
timeFrame: 12 weeks
Other outcomes:
measure: Blind evaluation
timeFrame: Week 4
measure: Abnormalities after the moxibustion
timeFrame: Week 4
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
state: Shanghai
Study officials:
affiliation: Shanghai Institute of Acupuncture and Meridian
name: Huangan Wu, PhD, MD
role: STUDY_CHAIR
References: