Investigation for Tiao-Gan Yi-Qi Ding-Ji Formula in the Treatment of Paroxysmal Atrial Fibrillation with Obstructive Sleep Apnea Hypopnea Syndrome through Series of N-of-1 Trial

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) OSAHS;
•(2) Paroxysmal atrial fibrillation;
•(3) TCM syndrome differentiation is Qi deficiency and blood stasis syndrome;
•(4) Frequent atrial fibrillation at least 2 times/month and a history of atrial fibrillation for 1 year or more;
•(5) Aging between 18 and 85 years;
•(6) Provide informed consent form.

•(1) Patients with central or mixed sleep apnea hypopnea syndrome;
•(2) Patients with obstructive, restrictive pulmonary ventilation dysfunction and severe pulmonary infection;
•(3) With regularly take sedative sleeping pills for a long time;
•(4) With uncontrolled severe thyroid dysfunction;
•(5) hypohepatia, liver enzyme> 2 times of the normal value and renal insufficiency, Male serum creatinine > 2.5 mg/dl (> 220 umo/l) women > 2.0 mg/dl (> 175 umo/l);
•(6) With blood system, nervous system and other serious primary diseases and malignant tumors;
•(7) Acute myocardial infarction, severe cardiac insufficiency (NYHA cardiac function grade III, IV or LVEF ? ?40%) and other serious arrhythmias in structural heart disease;
•(8) Obvious hemodynamic instability, acute cerebrovascular accidents and major surgery in the past 3 months;
•(9) Pacemaker implantation or perioperative patients;
•(10) Allergies or persons allergic to known ingredients of the studied drug;
•(11) Pregnant and lactating women or those with a pregnancy plan;
•(12) Subjects who participated in other clinical trials in the last 3 months
•(13) Reluctant to participate in the trial or to estimate poor compliance;
•(14) Less than 2 times / month of atrial fibrillation episodes after the end of the elution period.

发起方

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine