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The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibet Rhodiola Capsule | Experimental |
| |
| Placebo oral capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibet Rhodiola Capsule | Drug | 4 capsules, po, from admission up to 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average oxygen saturation | Average oxygen saturation was assessed by home sleep apnea testing(HSAT) | Change from Baseline to 84±4days |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest saturation | Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT) | baseline and 84±4days |
| Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | 100029 | China |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Placebo oral capsule | Drug | 4 capsules, po, from admission up to 84 days |
|
T90SaO2 in percentage(%) was assessed by home sleep apnea testing(HSAT)
| baseline and 84±4days |
| AHI | AHI was assessed by home sleep apnea testing(HSAT) | baseline and 84±4days |
| Heart rate variability | Heart rate variability was assessed by Holter | baseline and 84±4days |
| Coronary flow reserve | Coronary flow reserve was assessed by Ultrasonic Cardiogram | baseline and 84±4days |
| Platelet(PLT) count | PLT in 10^9/L | baseline, 28±2days and 84±4days |
| Low density lipoprotein-cholesterol(LDL-C) | LDL-C in mmol/L | baseline, 28±2days and 84±4days |
| Glycosylated hemoglobin (HbAlc) | HbAlc in percentage(%) | baseline and 84±4days |
| Epworth sleepiness scale (ESS) | questionnaire | baseline and 84±4days |
| Quality of life scale (WHOQOL-BREF) | questionnaire | baseline and 84±4days |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |