chronic insomnia
Conditions
Interventions
Intervention group:On the basis of the original medication, Life Enhancer probiotic capsules were given one capsule each time, twice a day for 3 months.
Control group:On the basis of the original medication, one placebo capsule was given twice a day for 3 months.
Sponsors
Shanghai Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) 45-70 years old 2) It meets the diagnostic criteria of chronic insomnia in the International Classification of Sleep Disorders, Third Edition (ICSD-3, 2014) 3) Voluntary subjects, able to read, understand and sign the informed consent form, cooperate with drug taking, follow up regularly and take samples.1) 45-70 years old 2) It meets the diagnostic criteria of chronic insomnia in the International Classification of Sleep Disorders, Third Edition (ICSD-3, 2014); 3) Voluntary subjects, able to read, understand and sign the informed consent form, cooperate with drug taking, follow up regularly and take samples.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergic or allergic constitution to the test drug; 2. Secondary insomnia caused by chronic pain, prostatic hyperplasia and other diseases; 3. The working and living environment can't guarantee suitable sleeping opportunities and sleeping environment (at least 8 hours before going to bed); 4. Serious physical illness or being in the acute stage of any disease; 5. It is known that you have dementia or mental illness and cannot cooperate; 6. Supplement probiotics related preparations and receive antibiotic treatment within 2 weeks before joining the group, including but not limited to other probiotic supplements, yogurt and other products; 7. There are cognitive and emotional drug adjustments within one month; 8. Have a history of drug abuse, or have a history of alcohol abuse in the past 6 months, or have other circumstances that reduce the possibility of joining the group or complicate the group according to the judgment of the researcher (alcohol abuse is defined as drinking more than 14 alcohol units per week, and one alcohol unit is a bottle of 350ml beer, 120ml wine or 30ml spirits with 40% alcohol content); 9. Have participated in any clinical research of other medical devices or drugs in the past 3 months; 10. Planned pregnancy during pregnancy, breastfeeding or research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of Pittsburgh Sleep Quality Index Scale (PSQI);Score of Athens Insomnia Scale(AIS);Score of Insomnia Severity Index (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of Mini-mental State Examination(MMSE);Score of Montreal Cognitive Assessment(MoCA);Score of Hamilton Anxiety Scale(HAMA);Score of Hamilton Depression Scale(HAMD);Routine blood test;Liver and kidney function;Blood sugar;Blood lipid;Routine stool test;Inflammation index (CRP, cytokines);Serum cortisol;Serum adrenocorticotropic hormone;Fecal flora; | — |
Countries
China
Contacts
Public ContactTao W
Shanghai Fourth People's Hospital
Outcome results
None listed