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Applied research on the Mian Wan Ge Yao umbilical moxibustion in insomnia patients with heart and spleen deficiency guided by the theory of "invigorating spleen and regulating spirit"

Applied research on the Mian Wan Ge Yao umbilical moxibustion in insomnia patients with deficiency of heart and spleen guided by the theory of "invigorating spleen and regulating spirit"

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000260
Enrollment
Unknown
Registered
2024-08-19
Start date
2023-07-24
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Control group:acupuncture
treatment group:Mian Wan Ge Yao umbilical moxibustion+acupuncture

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for insomnia; 2) Meet the diagnostic criteria of insomnia in traditional Chinese medicine and the syndrome standards of heart-spleen deficiency; 3) Pittsburgh Sleep Quality Index (PSQI) score > 7 before treatment; 4) Age 18-75 years old; 5) Patients who had not taken sedative hypnosis or psychotropic drugs within 14 days before enrollment, and had not been treated for insomnia within one month; 6) Volunteers who sign informed consent.

Exclusion criteria

Exclusion criteria: 1) The skin around Shenque point has damage, ulceration, inflammation and sensory disorders; (ii) alcoholics and/or psychotropic drug dependents and abusers; 3) Patients with serious organic diseases such as cardiovascular disease, liver and kidney function and serious mental illness; (4) People who are allergic to Chinese medicine, umbilical patch and allergic constitution used in this study; 5) Active ulcer and bleeding tendency; 6) Acute stage of severe coma, consciousness disorders.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index,PSQI;

Secondary

MeasureTime frame
Insomnia severity index,ISI;Hospital Anxiety and Depression Scale,HADS;Hamilton Anxiety Scale,HAMA;TCM symptom and sign score;

Countries

China

Contacts

Public ContactHuang Ruomei

Guangdong Provincial Hospital of Chinese medicine

269799556@qq.com13560425710

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026