Obstructive Sleep Apnea Hypopnea Syndrome of the Spleen Deficiency and Dampness Obstruction
Conditions
Interventions
Treatment Group:Routine Basic Treatment Combined with "Modified LGZGT"
Control Group:Routine Basic Treatment Combined with Doxofylline Tablets
Sponsors
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
23 Years to 75 Years
Inclusion criteria
Inclusion criteria: Western Medicine Diagnostic Criteria With reference to the Multidisciplinary Diagnosis and Treatment Guidelines for Adult Obstructive Sleep Apnea, the diagnostic criteria are (A + B) or C. A: Presence of at least one of the following conditions: 1)The patient complains of daytime sleepiness, non-restorative sleep, fatigue, or insomnia; 2)Awakening from sleep due to choking or gasping; 3)Bed partners or other witnesses report habitual snoring, breathing pauses, or both during the patient's sleep; 4)Confirmed diagnosis of hypertension, mental disorders, cognitive impairment, coronary heart disease, cerebrovascular disease, congestive heart failure, atrial fibrillation, or type 2 diabetes. B: Respiratory events greater than or equal to 5 times/hour as detected by Polysomnography (PSG). C: Respiratory events greater than or equal to 15 times/hour as detected by Polysomnography (PSG). Severity Classification of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) It is determined based on the Apnea-Hypopnea Index (AHI) and nocturnal lowest oxygen saturation (LSpO2) indicators: Mild: AHI 5-15 times/hour, LSpO2 85-90%; Moderate: AHI 15-30 times/hour, LSpO2 80-85%; Severe: AHI greater than 30 times/hour, LSpO2 less than 80%. Traditional Chinese Medicine (TCM) Syndrome Differentiation and Typing Criteria With reference to the Expert Consensus on TCM Diagnosis and Treatment of Snoring Disease, the diagnostic criteria for the syndrome of spleen deficiency with dampness obstruction complicated by blood stasis in "snoring disease" are as follows: Principal Symptoms: 1)Snoring during sleep with occasional pauses, and the snoring sound is low and weak; 2)Obesity with weight gain; 3)Dizziness and muzziness, mental forgetfulness, and lassitude during the daytime. Secondary Symptoms: 1)Heavy-headedness and drowsiness; 2)Loose stools; 3)Dry mouth but no desire to drink water. Tongue Manifestation: Swollen tongue with scalloped edges, pale-dark tongue proper, and thick white greasy tongue coating. Pulse Manifestation: Thready, slippery, and hesitant pulse. Inclusion Criteria 1)Meeting the above-mentioned diagnostic criteria of both Western medicine and TCM, and having moderate to severe conditions (AHI greater than 15 times/hour); 2)Aged 23-75 years old, regardless of gender; 3)Refusing modern medical treatment; 4)Voluntarily participating in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with sleep-disordered breathing caused by secondary factors; 2) Patients with comorbid mental disorders, severe cardiovascular and cerebrovascular diseases, endocrine system diseases, or liver and kidney dysfunction; 3) Patients with known allergies to the drugs in this prescription; 4) Pregnant or lactating women; 5) Patients taking other traditional Chinese medicines or participating in other clinical drug studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| apnea-hypopnea index(AHI);nocturnal lowest oxygen saturation(LSpO2);Body Mass Index(BMI);macrophage migration inhibitory factor(MIF);microRNA-223(MIR-223);interleukin-18 inflammatory factors(IL-18);traditional Chinese medicine syndrome scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| nocturnal lowest oxygen saturation;pulse;respiratory;blood pressure;SPO2; | — |
Countries
China
Contacts
Public ContactZhenghang Ge
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Outcome results
None listed