A Clinical Exploratory Study on the Treatment of Primary Hypotension (Heart Qi Deficiency Syndrome) with Guizhi Boosting Decoction

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086650

Enrollment

Unknown

Registered

2024-07-08

Start date

2024-07-12

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary hypotension

Interventions

experimental group:Guizhi Boosting Decoction

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Traditional Chinese medicine syndrome differentiation is characterized by insufficient heart qi; (2) Meets the Western medical diagnostic criteria for primary hypotension; (3) Age range from 18 to 75 years old, regardless of gender; (4) Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with orthostatic hypotension and other types of hypotension, as well as diagnosed hypertensive patients, whose diastolic blood pressure is below 60mmHg; (2) Confirmed uncontrolled heart failure with clinical symptoms or hemodynamic disorders (NYHA grade = III) and malignant arrhythmias (severe sinus bradycardia, high degree atrioventricular block, ventricular tachycardia, ventricular flutter, ventricular fibrillation, and apical torsion transition ventricular tachycardia, etc.); (3) Complicated with hepatic and renal insufficiency (alanine aminotransferase = 3 times the upper limit of normal value, estimated glomerular filtration rate<30 mL/min), major diseases of the blood system, major infectious diseases, active rheumatic and immune diseases, malignant tumors and psychosis; (4) Individuals who have experienced severe trauma or major surgery within the past six months, or have a tendency for bleeding; (5) Pregnant and lactating women, or those who are allergic to the investigational drug or its components; (6) Participants in other clinical trials.

Design outcomes

Primary

Measure	Time frame
MinSBP/DBP and avgSBP/DBP for 24-hour dynamic blood pressure monitoring;	—

Secondary

Measure	Time frame
Changes in the integral of heart qi deficiency syndrome before and after treatment;Family self-test blood pressure changes;Other values of 24-hour dynamic blood pressure monitoring;Changes in echocardiography;Changes in SF12 Quality of Life Scale;RASS pathway;NO/NOS/ET;	—

Countries

China

Contacts

Public ContactXue Mei

Chinese Academy of Traditional Chinese Medicine

meiar@126.com+86 135 8180 1296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026