Non organic insomnia
Conditions
Interventions
Buzhong Yiqi Tang Group:Granule of Buzhong Yiqi Tang
Control group:Placebo granule of Buzhong Yiqi Tang
Sponsors
Guangdong Provincial Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the western medicine diagnostic criteria of insomnia; 2. sleep latencyis over 30 minutes, and/or wake up at night more than 2 times per night, and/or the total sleep time<6 hours. Duration of those symptoms are more than 1 months; 3. Conform to the diagnostic criteriaof insomnia in TCM; 4. Conform to the differentiation standard of spleen and stomach qi deficiency syndrome; 5. Score of PSQI is between 7 to 21; 6. Aged 18-55 years old; 7. Stable vital signs, conscious, have certain expression and cognitive ability; 8. In the past 2 weeks,did not take sedative hypnotics, antipsychotic drugs, antibiotics, corticosteroids and other drugs; 9. Voluntary trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Does not conform to the inclusion criteria; 2. Pregnant or lactating patients; 3. Infection and fever in the last week; 4. Participated in other clinical trials in the past three months; 5. Previous history of gastrointestinal disease or gastrointestinal surgery.Patients with severe primary diseases such as cardiovascular, pulmonary, liver, kidney and hematopoietic systems; 6. Insomnia comorbid depression, anxiety, schizophrenia, mania, the standard score of SAS is=60, the standard score of SDS is=62; 7. Patients with a history of epilepsy, OSAHS, COPD, bipolar disorder, mental retardation, cognitive impairment, restless legs syndrome, etc.; 8. Within 6 months, use antibiotics, corticosteroids,immunomodulator , flora regulator and other drugs; 9. In the past 2 weeks, use sedative hypnotics, antipsychotic drugs,gastrointestinal motility drugs,laxative,antidiarrheal agent and other drugs; 10. BMI=28kg/m2 or BMI18.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI;GSRS;the level of blood cortisol;Composition and proportion of intestinal flora; | — |
Countries
China
Contacts
Public ContactLi Yan
Guangdong Provincial Hospital of TCM
Outcome results
None listed