Children suffering from chronic insomnia accompanied by attention deficits
Conditions
Interventions
Treatment Group:The Qianyang Anshen Formula was administered orally
Control Group:The placebo was formulated with one-tenth of the active ingredients of the original Qianyang Anshen Formula
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 7 and 12 years regardless of gender; Meet the diagnostic criteria for chronic insomnia disorder in Western medicine; Meet the traditional Chinese medicine (TCM) pattern differentiation criteria of Insomnia due to Excessive Heart and Liver Fire; Present with attention impairment (Attention impairment: The diagnostic criteria are based on the "Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)" regarding attention deficit. The SNAP-IV scale developed according to DSM-5 diagnostic standards is widely used internationally for evaluating attention in children. In this study the SNAP-IV scale is adopted as the assessment tool. Combined with functional near-infrared spectroscopy (fNIRS) the attention impairment status of participants can be effectively determined.); Voluntarily participate and are able to cooperate with data collection; Signed informed consent (Children aged 8 years or above must sign together with their legal guardians).
Exclusion criteria
Exclusion criteria: 1.Insomnia caused by physical discomfort such as coughing wheezing pain or itching; 2.Use of medications known to affect sleep (e.g. melatonin hypnotics psychotropic drugs etc.); 3.Presence of severe liver kidney neurological cardiovascular endocrine or hematological diseases; 4.Known allergy to the investigational drug; 5.Those who in the judgment of the physician are likely to be lost to follow-up; 6.Currently taking other medications for chronic illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in sleep efficiency before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in SNAP-IV scale scores before and after treatment;The change in relevant parameters of functional near-infrared spectroscopy (fNIRS) before and after treatment; | — |
Countries
China
Contacts
Public ContactJIang Yonghong
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed