Study on the Efficacy of Dingxuan Shuyu Decoction in Treating Hypertension Patients with Anxiety

Phase 1

• Conditions: Hypertension with Anxiety

• Registration Number: ITMCTR2000004096
• Lead Sponsor: Shuguang hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with essential hypertension who have taken antihypertensive drugs or meet the diagnostic criteria for hypertension in the Chinese Guidelines for the Prevention and Treatment of Hypertension 2010: without antihypertensive drugs, measure blood pressure three times on different days, and systolic blood pressure >=140mmHg and /Or patients with diastolic blood pressure >=90 mmHg;
2. Patient mental health questionnaires conducted by professional psychologists, including GAD7 Anxiety Disorder Screening Scale and Hamilton Anxiety Scale (HAMA), GAD7 >=5 points and <=14 points and Hamilton Anxiety Scale (HAMA) >=7 points and Patients with <=21 points;
3. Meet the syndrome differentiation standard of Yin deficiency and Yang hyperactivity in TCM;
4. A history of oral anti-anxiety drugs but intolerance occurred;
5. Aged between 35 and 85 years old;
6. Stop taking other similar Chinese medicines and proprietary Chinese medicines during clinical observation;
7. Those who can cooperate in filling out questionnaires and surveys, and those who give informed consent.

Exclusion Criteria

1. Acute myocardial infarction, unstable angina pectoris;
2. Patients with other heart diseases or severe cardiac insufficiency (NYHA cardiac function classification> Grade III);
3. Patients with poor control after standardized treatment of hypertension (blood pressure>170/105mmHg);
4. Severe arrhythmias, persistent rapid atrial fibrillation (average ventricular rate in a calm state> 100 beats/minute), atrial flutter (average ventricular rate in a calm state> 100 beats/minute), frequent ventricular early (24 hours ventricular Premature beats> 7200) or ventricular tachycardia;
5. Patients with severe primary diseases such as brain, liver, kidney, hematopoietic system;
6. Diabetic patients with unstable blood sugar control and diabetic ketoacidosis;
7. Patients with serious mental illnesses, such as hallucinations, delusions, panic and suicidal behaviors; Generalized Anxiety Disorder Scale (GAD-7 Scale)>14 points and Hamilton Anxiety Scale (HAMA)>21 points;
8. Women during pregnancy or lactation, as well as men and women of childbearing age who have recent birth plans;
9. Allergic patients who are allergic to the test drug.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GAD-7;Hamilton Anxiety Scale;

Secondary Outcome Measures

Name	Time	Method
blood pressure;TCM single symptom score;SRSS;TCM syndrome curative effect score;