chronic insomnia
Conditions
Interventions
Sequential group:During the day to give Xinning capsule (manufacturer: Xi'an Datang Pharmaceutical Co., LTD Department
Batch number: Z20080537), the patient was instructed to take oral medicine 30min after breakfast and lunch, 3 capsules per time
Zaoren Dihuang capsules were given at night, and patients were instructed
Zaoren Dihuang Group:Yuzaoren Dihuang Capsule (Manufacturer: Shaanxi Buchanggao New Pharmaceutical Co., LTD.
Batch number: National Medicine Approval Z20163120), 3 times/day, 3 capsules/time, 30min after morning, lunch and bedtime.
The Bellomiens group:Baile Mian Capsule (Manufacturer: Yangzijiang Pharmaceutical Group Co., LTD.
Batch number: Z20020131), 2 times/day, 4 capsules/time, oral administration 30min after breakfast and dinner.
Sponsors
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. In line with DSM-5 Western Medicine diagnostic criteria for insomnia disorder; 2. In line with the TCM diagnostic criteria of heart-liver blood deficiency, heart-fire disturbance type insomnia; 3. Aged 18-70 years old, including 18 and 70 years old, gender is not limited; 4. The course of disease was consistent with chronic insomnia disorder (>= 3 months); 5. Pittsburgh Sleep Quality Index (PSQI) >= 8 points; 6. Normal cognitive function, can complete the relevant scale evaluation; 7. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary insomnia (insomnia related to other mental disorders, sleep disorders caused by internal diseases, sleep disorders caused by substances), environmental sleep disorders, sleep apnea syndrome; 2. There are serious anxiety depression and suicidal tendencies; 3. With serious primary heart, liver, lung, kidney, blood or other serious survival diseases; 4. Allergic constitution, such as allergic history of two or more drugs or things; Or known allergy to the ingredients; 5. Subjects who participated in or were participating in clinical trials of other drugs within three months prior to enrollment; 6. Does not conform to the heart and liver blood deficiency, heart fire disturbs the syndrome type; 7. Dependence or abuse of alcohol, drugs and other substances; 8. History of head trauma, central nervous system diseases such as epilepsy, brain tumor, hemangioma, encephalitis, acute brain injury and so on; 9. Pregnant or lactating women and those planning to become pregnant soon; 10. Regular use of any drugs that affect the central nervous system or sleep, such as sleep AIDS, antidepressants, antipsychotics, and antiepileptics, within 2 weeks before enrollment. (However, during the clinical trial, according to the needs of the subject's condition and the judgment of the investigator, without affecting the efficacy of the tested drug, patients with severe insomnia can be given dexzopiclonide within 2 weeks of starting the drug, but not continuously for 2 weeks; For patients with early waking insomnia, Esazolam can be applied at night, but not continuously for 2 weeks. Benzodiazepines and other sedative and hypnotic drugs are prohibited within 12 hours before the evaluation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Index;Polysomnography; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome grading quantified integral;Hamilton Anxiety Scale;Hamilton Depression Scale; | — |
Countries
China
Contacts
Public ContactCui Wang
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed