Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

Launched by SHANGHAI INSTITUTE OF ACUPUNCTURE, MOXIBUSTION AND MERIDIAN · Jul 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called grain moxibustion to see how effective and safe it is for people struggling with insomnia, which is trouble falling asleep or staying asleep. The treatment will be applied at specific acupuncture points on the body. The trial is looking for participants aged 18 to 75 years who have been dealing with insomnia for more than three months and meet certain health criteria. To join, you should have a specific type of insomnia related to a deficiency of both the heart and spleen, as determined by Traditional Chinese Medicine.

If you decide to participate, you will receive this treatment to help improve your sleep, and you will be closely monitored for any effects. However, not everyone can join; for example, individuals with severe health issues like serious heart or liver diseases, as well as pregnant or breastfeeding women, cannot participate. This trial has not started recruiting participants yet, so there will be more information available soon if you’re interested in learning more about how to get involved.

Gender

ALL

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.