Insomnia (heart and spleen deficiency syndrome)
Conditions
Interventions
experimental group treatment group:Compound Eleutherococcus senticosus granules taken orally and Guipi granule simulator
Positive control group:Take Guipi Granule and compound Eleutherococcus senticosus granule simulator with boiling water
Sponsors
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old, gender is not limited; (2) Be able to read, understand, follow study procedures and independently complete sleep diaries; (3) Meet the diagnostic criteria of insomnia in China Guidelines for Diagnosis and Treatment of Insomnia (2017) by the Chinese Sleep Research Society; (4) In line with the "thirteenth Five-Year Plan" textbook "Chinese Internal Medicine" insomnia (deficiency syndrome) "heart and spleen deficiency syndrome" syndrome standards; (5) Self-reported sleep latency (SL)>30 minutes, and/or, number of nocturnal awakenings =2 times/night, and/or, self-reported total sleep time (TST)<6h, any of the above three sleep disorder symptoms =3 times per week for at least 1 month; (6) The total score of Pittsburgh Sleep Index Scale (PSQI) is more than 8;
Exclusion criteria
Exclusion criteria: (1) other sleep disorders, such as narcolepsy, sleep apnea syndrome, or sleep-related movement disorders; (2) other mental disorders (such as obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder, etc.); (3) The body temperature of the subject in the cold fever period or unexplained fever =37.3?; (4) During screening, the subjects' health questionnaire depression scale score =15 points; (5) During screening, subjects' scores on the generalized anxiety scale were =15 points; (6) Those who have drug or alcohol dependence, addiction or allergy to the drugs in this study; (7) Receive any hypnotic, antidepressant, antipsychotic, anticholinergic, memory enhancing drug, antihistamine, central analgesic, central muscle relaxant, central nervous stimulant, CYP3A inducer, CYP3A inhibitor, 1 week before the introduction period or within 5 half-lives of the drug (whichever is longer), Chinese medicine, proprietary Chinese medicine, or any other insomnia treatment that can improve sleep; (8) Use of any insomnia therapy, including cognitive behavioral therapy or cannabis, within 1 week prior to the first administration of the study drug (introduction period) or within 5 half-lives, whichever is older; (9) Participants who are taking other clinical trial drugs, or have a wash period of less than 2 weeks after stopping the trial; (10) Have severe gastrointestinal diseases (such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers) and other gastrointestinal diseases that affect drug absorption; (11) Patients with hepatic and renal insufficiency, severe neurological diseases, cardiovascular diseases, endocrine system diseases (such as diabetes, hyperthyroidism, etc.), autoimmune diseases and other contraindications; Abnormal liver and kidney function ALT, AST= 1.5 times the upper limit of normal value, Cr > the upper limit of normal value; (12) Pregnancy, lactation, or possible pregnancy in the study cannot be taken there; (13) The researcher believes that there are circumstances that are inappropriate to participate in this study.:;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale PSQI single factor;Insomnia Severity Index Scale (ISI);The change of TCM syndrome score;Mean subjective sleep Awakenings (sNAW);Mean subjective sleep latency (sSL) recorded by sleep diary;Mean subjective total sleep time (sTST);Average subjective sleep Wake time (sWASO);Use of sedative and hypnotic drugs; | — |
Countries
China
Contacts
Public ContactShenli
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Outcome results
None listed