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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025229

Enrollment

Unknown

Registered

2019-08-17

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-08-27

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

Conditions

Paroxysmal Atrial Fibrillation with Obstructive Sleep Apnea Hypopnea Syndrome

Interventions

Medicine versus Placebo:Tiao-Gan Yi-Qi Ding-Ji Formula versus placebo

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
;;	—

Secondary

Measure	Time frame
Clinical symptomatic effect;TCM syndrome effect;Quality of life score;	—

Countries

China

Contacts

Public ContactZhang Jingchun

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

zhangjingchun276@126.com+86 18601292386

Outcome results

None listed

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