Status:
UNKNOWN
Effect of Moxibustion Intervention on Insomnia Patients
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Insomnia
Moxibustion
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia. Describe participant po...
Detailed Description
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia. Describe participant po...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria of ICD-10 insomnia;
- 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);
- Pittsburgh Sleep Quality Index (PSQI) score \> 7 at baseline;
- The treatment plan used in this study is tolerable, cooperative and compliant;
- Regardless of gender, age 18-65 years old;
- Understand the procedure and content of the test, and voluntarily sign the informed consent;
Exclusion
- Participating in other clinical studies;
- Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
- there is a clear risk of suicide or danger to oneself or others;
- Exclude pregnant or lactating women, or those planning pregnancy;
- Persons with alcohol and drug dependence within 1 year prior to screening.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06171308
Start Date
January 1 2023
End Date
December 31 2025
Last Update
December 14 2023
Active Locations (1)
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1
moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）
Shanghai, Shanghai Municipality, China