A prospective randomized double blind controlled clinical study of Qinggan Jieyu granula in the treatment of primary insomnia
Phase 1
- Conditions
- Primary insomnia
- Registration Number
- ITMCTR2000003783
- Lead Sponsor
- Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
1. Between 35-65 age, no gender limit;
2. The diagnostic criteria of primary insomina refer to International Classification of sleep disorders (3rd Edition) edited by American Sleep Medicine Association;
3. The diagnostic standard of Fire derived from Stagnation of Liver-QI Type refer to Guidelines for the Clinical Research of Chinese Medicine New Drugs;
4. Volunteer to participate in the research and sign the written informed consent.
Exclusion Criteria
1. Pregnant and lactating women;
2. Combined with severe heart, liver, lung, kidney and other physical diseases and cancer patients;
3. Sleep disorders caused by nervous system diseases and psychosis;
4. Insomnia caused by drugs or alcohol;
5. alcoholics and drug addicts.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index, PSQI;
- Secondary Outcome Measures
Name Time Method SF-36;HAMD;TCM symptom scale;HAMA;SPIEGEL Questionnaires;