Overview

Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea

Status:
Unknown status
Trial end date:
2018-05-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shao-Ping Nie
Criteria
Inclusion Criteria:

1. Age >18 years, males or females;

2. HSAT or PSG testing within recent 3 months;

3. AHI 5-30 and lowest oxygen saturation<85%;

4. Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to
improve OSA;

5. Written informed consent.

Exclusion Criteria:

1. History of CPAP, Mandibular orthosis device, surgery, or other medications to improve
OSA;

2. Significant central sleep apnea;

3. Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use
of sleeping pills or sedatives, restless legs syndrome;

4. Histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or
severe valvular disease), cardiogenic shock and heart failure (NYHA or Killip class
3-4), persistent atrial or ventricular arrhythmias;

5. History of myocardial infarction, coronary revascularization, and a known degree of
stenosis > 75% of the coronary lesions;

6. Histories of known serious liver dysfunction (ALT or AST levels above 3 times the
normal limit), renal insufficiency (GFR<30ml/min), moderate and severe chronic
obstructive pulmonary disease, and pulmonary arterial hypertension;

7. Patients with malignant tumors, lymphoma and neuropsychiatric disorders;

8. Patients with major surgery or trauma within 3 months, and active bleeding or
cerebrovascular accident within 6 months;

9. History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte <90×10^9/L);

10. Breastfeeding, pregnant, or potentially fertile women;

11. Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or
patients with serious adverse effect;

12. Participation in other clinical trials in recent 3 months;

13. Patients who cannot complete this trial or comply with the protocol.