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Study on the effect and mechanism of treating anxiety and depression in elderly patients with hypertensio

Phase 1
Recruiting
Conditions
hypertension
Registration Number
ITMCTR2000003784
Lead Sponsor
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients with essential hypertension who have taken antihypertensive drugs or meet the diagnostic criteria of Hypertension in Chinese Guideline for Prevention and Treatment of Hypertension 2010: under the condition of not using antihypertensive drugs, blood pressure of patients with systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 90mmHg shall be measured three times on the same day;
2. The questionnaire on the mental health status of patients was conducted by professional psychological consultants, including GAD7 anxiety Screening Scale and Hamilton anxiety Scale (HAMA), GAD7>= 5 and <=14 points, Hamilton Anxiety scale (HAMA) >= 7 and <= 21 points, and Hamilton Depression Scale (HAMD) >= 7 and <= 24 points.
3. Conform to the syndrome differentiation standard of Yin deficiency and Yang hyperactivity in TCM;
4. Age in 60~90 years old, gender is not limited;
5. Stop taking other similar Traditional Chinese medicines and proprietary Chinese medicines during clinical observation;
6. Cooperate with the questionnaire and the investigator, informed consent.

Exclusion Criteria

1. Acute myocardial infarction, unstable angina pectoris;
2. Patients with other cardiac diseases or severe cardiac insufficiency (NYHA cardiac function grade > level III);
3. Patients with poor control after standardized treatment of hypertension (blood pressure > 170/105mmhg);
4. severe arrhythmia, continuous rapid atrial fibrillation (calm state average ventricular rate > 100 times/min), atrial flutter (calm state average ventricular rate > 100 times/min), frequent ventricular premature beats (24 hours of premature ventricular beats > 7200 times) or ventricular tachycardia;
5. patients with severe primary diseases such as brain, liver, kidney and hematopoietic system;
6. Diabetic patients with unstable blood glucose control and diabetic ketoacidosis;
7. Patients with severe mental illness, such as hallucinations, delusions, panic attacks and suicidal behavior;
8. Women who are pregnant or breast-feeding, and men and women of childbearing age who have recently had family planning;
9. Patients with allergic constitution who are allergic to the tested drugs.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
gallbladder contraction;Hamilton Depression Scale (HAMD) score;Score on the GAD7 Anxiety screening scale;Hamilton Anxiety Scale (HAMA) score;Corticotropin;
Secondary Outcome Measures
NameTimeMethod
blood pressure;Sleep Status Self-rating scale;Plasma serotonin;Blood pressure variability;glutamate;Integral of TCM syndrome curative effect;
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