Insomnia
Conditions
Sponsors
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
30 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. The main complaint is insomnia, and it meets the diagnostic criteria of insomnia in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2017 Edition)"; 2. Female, aged 30-59 years old; 3. The duration of insomnia is >=1 month; 4. Pittsburgh Sleep Quality Index (PSQI) score >= 7; 5. Subjects informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with secondary insomnia, those diagnosed with anxiety or depression; those whose self-rating scale meets the state of anxiety or depression; 2. Subjects who regularly took insomnia and anti-anxiety and depression drugs before enrollment; 3. Diagnosed and required medication for various acute and chronic diseases such as hematopoietic system, endocrine system, respiratory system, circulatory system, digestive system, genitourinary system, nervous system, immune system, mental system (except for hypertension with systolic blood pressure lower than 160mmHg), have bleeding tendency, various trauma, skin diseases, tumor history, liver function is higher than 1.5 times the upper limit of normal, and Cr is higher than normal; 4. Those who are taking any form of traditional Chinese medicine preparations, nutritional products, and health products; 5. People with allergies or allergies to bee products or animal protein; 6. Women who are pregnant or breastfeeding, women who have recent pregnancy plans or contraceptive drugs; 7. Other issues that the researcher thinks may limit the effect evaluation or follow-up; 8. Patients who have participated in clinical trials of other drugs in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severe Index;Traditional Chinese Medicine Measurement Scale of Female Aging Status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Insomnia Traditional Chinese Medicine Syndrome Diagnostic Scale;Sub-Health Measurement Scale;Fatigue Scale-14;Aspartate aminotransferase;Alanine aminotransferase;Creatinine;Urea nitrogen;Follicle stimulating hormone;Luteinizing hormone;Estradiol;Free thyroxine;Free triiodothyronine;Thyroid stimulating hormone;Homocysteine;High-sensitivity C-reactive protein;Apolipoprotein A1;Interleukin-6;Tumor necrosis factor-a;Interleukin-1ß;Nuclear transcription factor-?B, NF-?B;Infrared thermography testing; | — |
Countries
China
Contacts
Public ContactChen Ying
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Outcome results
None listed