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Observation on the Clinical Efficacy of Lu Qi Zengmai Formula for the Treatment of Slow Arrhythmia in Syndrome of Yang Deficiency in Heart and Kidney

Observation on the Clinical Efficacy of Lu Qi Zengmai Formula for the Treatment of Slow Arrhythmia in Syndrome of Yang Deficiency in Heart and Kidney

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001098
Enrollment
Unknown
Registered
2026-04-28
Start date
2023-11-30
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Slow arrhythmia

Interventions

Liqui-Yi Pulse-Enhancing Formula Granules:Oral Deer and Huangqi Blood Circulation Promoting Formula Granules
Lurong-Huangqi Zengmaifang Decoction:Oral Deer Astragalus Augmenting Pulse Formula Decoction
Placebo:Oral Placebo Solution

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria of Western medicine Referring to the relevant definition of bradycardia in Cardiology [15], formulate: 1) Sinus bradycardia: The average heart rate on a dynamic electrocardiogram is less than 60 beats per minute, or the total 24-hour heart rate is less than 80000 beats per minute. 2) Sick sinus syndrome: mainly manifested as sinoatrial conduction block, sinus arrest lasting more than 2 seconds, or sinus bradycardia (heart rate less than 50 beats per minute for a long time). If sinus bradycardia is isolated, a positive atropine test is required. 3) Atrioventricular block: Grade II atrioventricular block: Type I, with regular P-wave appearance and gradually prolonged PR interval until a QRS complex is lost after the P-wave; Type II, with fixed PR interval and partial detachment of QRS complex after P wave. Third degree atrioventricular block: P wave is not related to QRS complex, atrial rate is faster than ventricular rate, QRS duration is normal or prolonged. 2. Diagnostic criteria for traditional Chinese medicine syndromes Referring to the "Guidelines for Clinical Research of Traditional Chinese Medicine New Drugs (1995 Edition)" [17] in "Traditional Chinese Medicine Cardiology" [16], the relevant standards for heart palpitations and kidney yang deficiency syndrome were formulated: Main symptoms: 1) palpitations and restlessness; Secondary symptoms: 1) pale complexion; 2) Afraid of cold limbs; 3) Mental lethargy; 4) Weakness and soreness in the waist and knees; 5) The leader is dizzy. Tongue pulse: The tongue is light and plump, with white and smooth coating; The pulse is deep, slow, subtle, or complex, or astringent. Diagnostic criteria of traditional Chinese medicine: possessing the main symptoms of palpitations and restlessness; Has two secondary symptoms and supporters of tongue and pulse. (2) Inclusion criteria 1) Meets the diagnostic criteria for chronic arrhythmia in Western medicine; 2) Meets the diagnostic criteria of traditional Chinese medicine and is diagnosed with heart kidney yang deficiency syndrome; 3) Age between 18 and 80 years old; 4) Antiarrhythmic drugs have been discontinued for more than 5 half lives or have not been taken before; 5) Informed consent and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Individuals under 18 years old or over 80 years old; 2) Pregnant or lactating women; 3) Allergic constitution and individuals who are allergic to this medication; 4) Patients with sinus bradycardia accompanied by paroxysmal atrial fibrillation, atrial flutter, and supraventricular tachycardia; 5) Individuals with sinus node impulse formation and conduction disorders caused by medication, neurological, and metabolic dysfunction; 6) Patients with severe primary diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic systems, as well as psychiatric patients; 7) Patients with an average ventricular rate below 40 beats per minute, or sinus arrest lasting more than 3 seconds on a 24-hour dynamic electrocardiogram, or patients with grade II type II atrioventricular block or above. 8) Individuals with a heart rate of less than 60 beats per hour but who have experienced repeated fainting. 9) Those who have already installed pacemakers; 10) Failure to use medication according to regulations, inability to assess efficacy, or incomplete data that affects efficacy or safety.

Design outcomes

Primary

MeasureTime frame
24-hour Holter electrocardiogram total heartbeats count, average heart rate;

Secondary

MeasureTime frame
TCM Syndrome Score;TCM Single Symptom Score;

Countries

China

Contacts

Public ContactShen Lin

Longhua Hospital Shanghai University of Traditional Chinese Medicine

cathylin927@126.com18720067093

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026