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A multicenter, randomized, single blind, placebo-controlled clinical study on the treatment of paroxysmal atrial fibrillation (Yin Yang deficiency syndrome) with Zhi gancao Decoction

A multicenter, randomized, single blind, placebo-controlled clinical study on the treatment of paroxysmal atrial fibrillation (Yin Yang deficiency syndrome) with Zhi gancao Decoction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085614
Enrollment
Unknown
Registered
2024-06-13
Start date
2024-01-24
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Paroxysmal atrial fibrillation

Interventions

Control Group:Metoprolol sustained-release tablets, 47.5mg/time, once a day. Placebo granules.
Traditional Chinese Medicine Experimental Group:Metoprolol sustained-release tablets, 47.5mg/time, once a day. Zhi gancao Decoction granules.
Healthy population control group:None

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with paroxysmal atrial fibrillation by Western medicine should refer to the 2020 ESC/EHRA/EACTS Diagnosis and Management Guidelines for Atrial Fibrillation: Atrial fibrillation that terminates or intervenes within 7 days of onset; 2) The diagnostic criteria for traditional Chinese medicine are formulated in accordance with the "Guiding Principles for Clinical Research of New Chinese Medicines" for central palpitations, and the diagnosis is based on the deficiency of yin and yang; 3) Individuals aged between 18 and 85 who have signed an informed consent form; 4) Individuals who have been diagnosed with atrial fibrillation by routine 12 lead electrocardiogram or dynamic electrocardiogram within the past three months.

Exclusion criteria

Exclusion criteria: 1) Patients with allergy to the ingredients of Zhi gancao Decoction and contraindications to ß -blockers; 2) prolongation of QT interval (Q-Tc> 480ms), bradycardia (heart rate 160mmHg and / or diastolic blood pressure> 100 mmHg).

Design outcomes

Primary

MeasureTime frame
superoxidedismutase,SOD;malondialdehyde,MDA;Metabolism of serum;

Secondary

MeasureTime frame
Atrial fibrillation burden;left ventricular function;TCM syndrome score;

Countries

China

Contacts

Public ContactZhou Qian

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

njzhouqian@njucm.edu.cn+86 139 5185 0627

Outcome results

None listed

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