Moxibustion treatment for insomnia patients
Effect of Moxibustion Intervention on Insomnia Patients
This study is testing if adding moxibustion to standard treatments can help people with insomnia sleep better and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06171308 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of moxibustion combined with Traditional Chinese medicine and Western medicine in treating insomnia. A total of 120 insomnia patients will be randomly assigned to either a treatment group receiving moxibustion and Western medicine or a control group receiving only Western medicine. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI) to evaluate changes in sleep quality. Secondary outcomes will include quality of life measures and adverse reactions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who meet the diagnostic criteria for insomnia and have a PSQI score greater than 7.
Not a fit: Patients with serious physical diseases or those participating in other clinical studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for patients suffering from insomnia.
How similar studies have performed: While the combination of moxibustion with Western medicine is less commonly studied, similar approaches in Traditional Chinese medicine have shown promise in treating various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the diagnostic criteria of ICD-10 insomnia; 2. In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse); 3. Pittsburgh Sleep Quality Index (PSQI) score \> 7 at baseline; 4. The treatment plan used in this study is tolerable, cooperative and compliant; 5. Regardless of gender, age 18-65 years old; 6. Understand the procedure and content of the test, and voluntarily sign the informed consent; Exclusion Criteria: 1. Participating in other clinical studies; 2. Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test; 3. there is a clear risk of suicide or danger to oneself or others; 4. Exclude pregnant or lactating women, or those planning pregnancy; 5. Persons with alcohol and drug dependence within 1 year prior to screening.
Where this trial is running
Shanghai, Shanghai
- moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD） — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: JING Cai, Undergraduate
- Email: 1994510cj@163.com
- Phone: 13524000307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.