chronic insomnia
Conditions
Interventions
Controlled group:Hehuan Anshen granules with a 10% drug concentration
Experimental group:Hehuan Anshen granules
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 81 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged >= 18 years; 2. Clear consciousness normal hearing and visual abilities are maintained and have the ability to participate in the neuropsychological activity test; 3. Participants meet diagnostic criteria for Chronic insomnia in ICSD-3 and with daytime fatigue at the same time. 4. According to the "internal medicine of traditional Chinese medicine" it meets the diagnostic criteria of "insomnia disease" and conforms to the syndrome types of liver fire disturbing the heart phlegm heat disturbing the heart deficiency of both heart and spleen heart kidney disharmony deficiency of heart and gallbladder Qi etc. 5.The total score of PSQI is above 8; 6. The total score of FFS is above 14; 7. Participants agree to sign the informed consent form and volunteer for this study
Exclusion criteria
Exclusion criteria: (1) Participants with other sleep disorders such as narcolepsy sleep apnea syndrome or sleep related motor disorders; (2) Participants with Any history of severe mental illness; (3) Participants with obvious depressive symptoms with a score of>29 on the Beck Depression Inventory II (BDI) Depression Scale; (4) Participants with medication alcohol dependence addiction or allergies to the drugs in this study; (5)Participants were taking antipsychotic medication that impact the assessment of efficacy; (6) Any participant on treatment were withdrawn from other clinical drug trials before the first study-drug administration were less than 2 weeks. (7) Participants with serious gastrointestinal diseases (such as indigestion gastrointestinal obstruction gastroduodenal ulceration) and serious secondary diseases that affect drug absorption; (8) Participants comprised hepatic and renal dysfunction severe neurological diseases cardiovascular and cerebrovascular diseases' complication as well as a history of other autoimmune diseases and any other contraindication; (9) Female participants who are pregnant breastfeeding or may not be able to take effective contraceptive measures during research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Index Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale;Traditional Chinese Medicine Symptom Scale;Flinders Fatigue Scale;Insomnia Severity Scale; | — |
Countries
China
Contacts
Public ContactXu Jian
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM
Outcome results
None listed