Insomnia disorders
Conditions
Interventions
Treatment Group:The treatment group was treated with Shugan Jianpi Yangxin granule, twice a day. For 4 weeks.
Control group:The control group was treated with placebo of liver-soothing, spleen-strengthening and heart-nourishing formula,twice a day. For 4 weeks.
Sponsors
The First Affiliated Hospital of He'nan University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects were also required to meet the following criteria: 1. Aged 18-60 years (including 18 and 60) , gender is not limited; 2. Accord with the diagnostic standard of Western medicine for chronic insomnia disorders; 3. It is in accordance with the diagnostic standard of TCM syndrome type of insomnia of stagnation of liver-qi and deficiency of the spleen; 4. Those who had not taken any Western medicine, Chinese patent medicine or decoction for insomnia in the past week; 5. PSQI scores 7-15 points; 6. Voluntarily cooperate with the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Can not be enrolled with any of the following: 1. Patients who must regularly take sleeping aids or health products; 2. Having other relevant medical histories that affect sleep: narcolepsy, circadian rhythm sleep disorder, sleepwalking, sleep-related breathing disorder, obstructive or central sleep apnea syndrome, restless leg syndrome, etc.; 3. A history of severe mental illness or affective disorder (e.g., anxiety disorder, depression, suicidal tendency or history of suicide) , or long-term use of central nervous system or stimulants in the past 1 year; 4. Hamilton Anxiety Rating Scale score >= 14 or Hamilton depression scale score >= 17 at enrollment screening; 5. There were other causes of insomnia, such as pain, fever, cough, operation, environmental interference or stressful life events in the past 1 month; 6. Patients with severe physical diseases, such as cardio-cerebrovascular diseases, lung, liver, kidney and hematopoietic system, or central nervous system disease, or cancer; 7. Liver function ALT and AST were 1.5 times higher than the upper limit of normal reference value, or SCR was higher than the upper limit of normal reference value; 8. Allergic to known components of the drug used; 9. Pregnant and lactating patients; 10. Alcoholics, drug abusers and psychoactive drug addicts; 11. Participated in clinical trials of other drugs in the past month; 12. Researchers consider it inappropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography;Sleep Diary;blood serum index;Hamilton Anxiety Scale, HAMA;TCM syndrome scale; | — |
Countries
China
Contacts
Public ContactZhang Jie
The First Affiliated Hospital of He'nan University of TCM
Outcome results
None listed