insomnia
Conditions
Interventions
Test group: Zaoren Anshen capsule and 1/2 dose of Zolpidem tartaric
1/2 positive group:Zaoren Anshen capsule simulation agent and 1/2 dose of Zolpidem tartaric
positive group:Zaoren Anshen capsule simulation agent and Zolpidem tartaric
control group:Zaoren Anshen capsule Zolpidem tartaric simulation agent
Sponsors
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In accordance with insomnia diagnostic criteria(ICSD3,the American Academy of Sleep Medicine,2014); 2. Seven factors'accumulative points of Pittsburgh sleep quality index>7 points; 3. Course of insomnia longer than 3 months; 4. Aged 18 and 65 years male and female; 5. Voluntary subjects, obtain informed consent process comply with GCP; 6. Cultural level: third grade or above.
Exclusion criteria
Exclusion criteria: 1. Professional drivers,High-altitude operators; 2. the person who didn't use any other drugs for the treatment of insomnia; 3. pregnancy and lactation women; 4. With serious primary heart, liver, lung, kidney, blood disease, or seriously affect the survival, such as cancer or AIDS, Liver and kidney dysfunction; 5. Allergic to Zolpidem Tartrate Tablets,Decompensated patients with respiratory insufficiency, myasthenia gravis, Severe sleep apnea syndrome; 6. Have a mental disorder Patients and patients with severe epilepsy; 7. A history of alcohol and drug abuse; 8. According to the judgment of the researchers, have lower possibility into the group or complicate the group's other lesions, such as working environment change often easy to cause lost to follow-up; 9. allergic constitution; 10. Participated in or is in other drug clinical trial subjects within three months; 11. pregnant woman,persons who have bradycardia, hypotension and gastrointestinal diseases (canker, gastroenteritis); 12. person who is suffering from serious diseases such as cancer, chronic obstructive pulmonary disease (copd), primary closed-angle glaucoma patients; 13. Patients with moderately severe anxiety depression: HAMA>14 points,HAMD>17 points.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of the insomnia severity index;Reduction rate of PSQI;sleep time in the sleep diary;Alertness test;Neural electrophysiological testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;Blood lipid;blood glucose;Reduction rate of Hamilon anxiety scale;Reduction rate of Hamilon depression scale; | — |
Countries
China
Contacts
Public ContactJingfang Gao
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Outcome results
None listed