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Professor Deng Tietao a master of traditional Chinese medicine conducted a clinical efficacy and mechanism study on the "Astragalus and Ephedra Formula" in different dosage forms for the stable period of threshold in patients with bradyarrhythmia after pacemaker implantation.

Professor Deng Tietao a master of traditional Chinese medicine conducted a clinical efficacy and mechanism study on the "Astragalus and Ephedra Formula" in different dosage forms for the stable period of threshold in patients with bradyarrhythmia after pacemaker implantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000722
Enrollment
Unknown
Registered
2024-11-22
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Pacemaker Implantation Postoperative Period for Bradyarrhythmia

Interventions

Decoction Treatment Group:Standardized Western Medical Treatment plus QMXF Decoction Treatment Group
control:Standardized Western Medical Treatment
Granule Half-Dose Treatment Group:Standardized Western Medical Treatment plus Granule Half-Dose Treatment
Granule Normal Dose Treatment Group:Standardized Western Medical Treatment plus Granule Normal Dose Treatment

Sponsors

Guangzhou University of Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western medical diagnostic criteria for bradyarrhythmia and have undergone permanent pacemaker implantation for more than 3 months. (2) Age between 18 and 80 years old, with no gender restrictions. (3) Good compliance, able to provide contact information, and can be followed up regularly. (4) Voluntarily participate, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have experienced pocket wound dehiscence, pocket skin necrosis, or pocket infection after pacemaker surgery. (2) Patients who require continuous administration of other antiarrhythmic drugs or drugs that significantly affect heart rate. (3) Patients with severe heart failure (NYHA functional class III-IV). (4) Patients with uncontrollable malignant arrhythmias or more than two complex arrhythmias. (5) Patients who have undergone or plan to undergo coronary revascularization treatment within 1 month or 3 months. (6) Patients with progressive acute coronary syndrome. (7) Patients with uncontrolled hypertension, with systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg. (8) Patients in cardiogenic shock. (9) Patients with left ventricular outflow tract obstruction, myocarditis, aortic aneurysm, dissecting aortic aneurysm, or uncorrected heart valve disease causing significant hemodynamic changes. (10) Patients with a history of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or stroke of undetermined type) or lower limb arterial disease within the last 6 months. (11) Patients with a history of active bleeding disorders within the last 6 months. (12) Patients with concurrent tumors, severe endocrine system diseases, mental disorders, severe primary diseases of the liver and kidneys, or severe hematopoietic system diseases. (13) Patients who are pregnant, have been pregnant within the last 6 months, are planning to become pregnant, have had a miscarriage, or are in the postpartum period including after childbirth, abortion, or delivery. (14) Patients with allergic constitutions or known allergies to treatment drugs. (15) Patients participating in other clinical trials. (16) Patients who, according to the investigator's judgment, cannot complete this study. (17) Patients with a life expectancy of less than 3 months.

Design outcomes

Primary

MeasureTime frame
Pacing Ratio;

Secondary

MeasureTime frame
6-Minute Walk Test;Traditional Chinese Medicine Syndrome Score;Perception Threshold, Catheter Impedance, 24-Hour Heart Rate Trend, Battery Status, Atrial Fibrillation Burden, Heart Failure Index;Minnesota Living with Heart Failure Questionnaire;Cardiovascular Events: New-Onset Heart Failure New-Onset Atrial Fibrillation Acute Exacerbation of Chronic Heart Failure;

Countries

China

Contacts

Public ContactQingmin Chu

Guangzhou University of Chinese Medicine First Affiliated Hospital

13929504676@163.com13929504676

Outcome results

None listed

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