Chronic insomnia (Western medical diagnosis) and insomnia (heart and liver blood deficiency syndrome) (Traditional Chinese Medical diagnosis)
Conditions
Interventions
Experimental Group:Yiqi Yangxin Anshen Oral Liquid, 1 vial each time, 3 times daily, 1 hour after meals by mouth.
Control Group:Yi Qi Yang Xin An Shen Oral Liquid Placebo, 1 vial each time, 3 times daily, to be taken orally 1 hour after meals.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 70 years old; (2) Meeting the diagnostic criteria for chronic insomnia in Western medicine; (3) Meeting the diagnostic criteria for insomnia () in Traditional Chinese Medicine; (4) Meeting the criteria for deficiency of heart and liver blood syndrome; (5) Having signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals preparing for pregnancy, during pregnancy, breastfeeding, or those who need to accompany children while sleeping; (2) Patients confirmed by medical history and consultation to have secondary insomnia caused by other diseases, such as restless legs syndrome, acute or chronic heart failure, chronic obstructive pulmonary disease, or acute or chronic bronchitis; (3) Patients diagnosed with severe depression using the Patient Health Questionnaire-9 (PHQ-9) (total score =15) or diagnosed with severe anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale (total score =15); (4) Patients classified as having severe insomnia based on the Insomnia Severity Index (ISI) (total score =22); (5) Patients with cancer and a remission period of less than 5 years; (6) Individuals who have participated in other drug clinical trials within the past 30 days; (7) Patients with other mental disorders; (8) Patients with hemoglobin levels below 90 g/L, white blood cell counts less than 3.0 × 10^9/L, or platelet counts below 100 × 10^9/L; (9) Patients with a glomerular filtration rate below 40 ml/min; (10) Patients with aspartate aminotransferase or alanine aminotransferase levels exceeding 1.5 times the upper limit of the normal range; (11) Night shift or rotating shift workers and individuals with irregular bedtime schedules (i.e., bedtime outside of 9 PM and midnight); (12) Patients allergic to the investigational drug; (13) Patients with finger or nail injuries, severe skin diseases, or skin damage, absent fingers, or non-removable jewelry on the wrist; (14) Patients with metal implants or pacemakers in the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Depression Screening Tool;Generalized Anxiety Disorder Scale;Traditional Chinese Medicine Deficiency and Excess Scale;Traditional Chinese Medicine Constitution Scale;Pulse Meter;Human Bioelectromagnetic Induction;Nail fold vascular microcirculation; | — |
Countries
China
Contacts
Public ContactYang Zhimi
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed