Traumatic Brain Injury Combined with Emotional and Sleep Disorders
Conditions
Interventions
Experimental group:Shuganjieyu Capsules, specification: 0.36g, 2 capsules per dose, taken twice a day, once in the morning and once in the evening.
Control group:Improved Taiji Digital Exercise Prescription, exercise mode: online Taiji Quan training
Combined group:Shuganjieyu Capsules combined with the Improved Taiji Digital Exercise Prescription.
Sponsors
Beijing Tian Tan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 75 years old (including 18 and 75), gender not limited; Patients with a history of head trauma within 1 year, 9= Glasgow Coma Scale (GCS) score =15, and able to cooperate with the corresponding examinations; Screening period Hamilton Rating Scale for Depression-17 items (HAMD-17) score =18 points, symptom duration =1 week and severely affecting daily life; Willing to sign an informed consent form and agree to participate in all visits, examinations, and treatments according to the trial protocol.
Exclusion criteria
Exclusion criteria: Patients with active cerebral hemorrhage; acute stage of cerebral contusion and laceration, epidural and subdural hemorrhage; Patients in the unstable period of post-traumatic epilepsy; Patients who meet the diagnostic criteria for other mental disorders in DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders) and have a history of depression, anxiety, or other mental disorders; Treatment-resistant depression (clinical efficacy is not satisfactory after taking two or more antidepressants with sufficient dose and course of treatment of different mechanisms); Depression caused by psychoactive drugs; Patients with severe suicidal tendencies (HAMD-17 suicide rating score =3) or tendencies to harm others; Patients with severe or unstable cardiovascular, liver, kidney, endocrine, digestive, blood, and other internal medicine diseases; Patients with ALT and AST > 2 times the upper limit of the reference value or Scr > the upper limit of the reference value; Patients with a history of endocrine diseases such as hyperthyroidism and hypothyroidism, and currently in the active phase; Patients who have undergone psychiatric surgery or electroconvulsive therapy in the past 3 months; Patients with allergic constitution, known or suspected history of allergy to Hypericum perforatum L. or Eleutherococcus senticosus; Patients who have been previously treated with Shuganjieyu Capsules without efficacy; Pregnant and lactating women, and those who plan to become pregnant during the trial and within 6 months after the trial; Patients who have abused or depended on psychoactive substances in the past 12 months; Long-term users of caffeine and nicotine; Patients who have received or are currently receiving any other clinical trial drugs within 1 month before the trial; Patients who are taking drugs that interfere with the efficacy evaluation of the investigational drug, or drugs that are contraindicated for use with the investigational drug, or patients who have received systematic treatment with antidepressants within 4 weeks; Patients with metal implants such as cardiac pacemakers, artificial cochlea, and stents; Other patients who are considered unsuitable by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of the HAMD-17 total score relative to baseline after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change value of the HAMA total score relative to baseline after 12 weeks of treatment;;Change value of total score on the PSQI, ISI, ESS, and traditional parameters on PSG relative to baseline after 12 weeks of treatment;;Change value of the MoCA total score relative to baseline after 12 weeks of treatment;;Change value of the SDS total score relative to baseline after 12 weeks of treatment;;Change value of the fNIRS and ERP indicators relative to baseline after 12 weeks of treatment.; | — |
Countries
China
Contacts
Public ContactWang Chunxue
Beijing Tian Tan Hospital, Capital Medical University
Outcome results
None listed