Last updated: December 6, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Insomnia
Treatment
Traditional Chinese moxibustion apparatus
Clinical Study ID
NCT06171308
2022-YJ14
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Meet the diagnostic criteria of ICD-10 insomnia;
- In line with the relevant diagnostic criteria of TCM syndrome differentiation ofheart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria accordingto the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment ofInsomnia 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 informedconsent;
Exclusion
Exclusion Criteria:
- Participating in other clinical studies;
- Exclude patients with serious physical diseases or diseases that may affect theevaluation 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.
Study Design
Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Traditional Chinese moxibustion apparatus
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
moxibustion equipment(Zhongshan Jiaxun medical equipment Co., LTD)
Shanghai, Shanghai
ChinaActive - Recruiting
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