Hypertension with depression
Conditions
Interventions
treatment group:Conventional antihypertensive treatment + Shugan Jieyu capsule
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18-70 years old (including the limit value), gender is not limited; 2. In accordance with the diagnostic criteria of hypertension in the Chinese Guidelines for Hypertension Prevention and Treatment (2018) : In the absence of antihypertensive drugs, the blood pressure in the office was measured three times on different days, with SBP >=140 mmHg and (or)DBP >=90 mmHg; 3. The previous 1 month hypertension treatment plan was stable and the blood pressure control was stable; 4. One of the following two criteria should be met: (1) Depressive symptoms (depressive mood or symptoms of reduced interest) occur continuously for =2 weeks, and the PHQ-9 score remains >=10 points; (2) Patients who had used mood regulating proprietary Chinese medicines for more than 2 weeks had no improvement in depressive symptoms, and the PHQ-9 score continued to be >=10 points.
Exclusion criteria
Exclusion criteria: 1. Those who meet the DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, anxiety disorders, compulsive and related disorders, somatic symptoms and related disorders, etc.); 2. Previous history of depression, anxiety or other mental disorders; 3. There are suicidal thoughts or behaviors; 4. Patients with serious or unstable cardiovascular and cerebrovascular, liver, kidney, endocrine, digestive, blood and other internal diseases; 5. Liver function test ALT, AST > 2 times the upper limit of reference value, or Scr > the upper limit of reference value; 6. Patients who have a history of endocrine diseases such as hyperthyroidism and hypothyroidism and are currently in the active stage; 7. Patients who have undergone psychosurgery or electroconvulsive treatment in the last 3 months; 8. Allergic people, known or suspected to hypericum perforatum, Acanthopanax have allergic history; 9. Patients who have failed to receive previous treatment with Shugan Jieyu capsule, or stop taking Shugan Jieyu capsule within 1 month; 10. Pregnant and lactating women, those planning pregnancy during the trial and within 6 months; 11. Patients with psychoactive substance abuse or dependence within the last 12 months; 12. Those who have received or are receiving any other investigational drug treatment within 1 month prior to the trial; 13. Patients who are taking or have previously been treated with antidepressant systems; 14. The investigator considered other participants unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall validity of The Patient Health Questionnaire (PHQ-9) scores at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall validity of The Patient Health Questionnaire (PHQ-9) scores at 4 and 8 weeks of treatment;Cure rate, change value, and reduction rate of The Patient Health Questionnaire (PHQ-9) score at 4, 8, and 12 weeks of treatment;Overall Effectiveness, Cure Rate, Change Value, and Rate of Decrease in Generalized Anxiexy Disorde-7 (GAD-7) Score at 4, 8, and 12 Weeks of Treatment;Overall Effectiveness, cure rate, change value, and reduction rate of The Health Questionnaire-15 (PHQ-15) scores at 4, 8, and 12 weeks of treatment;Blood pressure lowering values, blood pressure lowering efficiency, lowering distribution and blood pressure variability at 12 weeks of treatment;cardiopulmonary exercise testing;Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 4, 8, and 12 Weeks of Treatment Values;Change from Baseline in the Health Questionnaire (SF-36) Scores at 12 Weeks of Treatment Values; | — |
Countries
China
Contacts
Public ContactLuo Suxin
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed