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

Phase 1

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation with Obstructive Sleep Apnea Hypopnea Syndrome

• Registration Number: ITMCTR1900002531
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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Secondary Outcome Measures

Name	Time	Method
TCM syndrome effect;Quality of life score;Clinical symptomatic effect;