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

Shao-Ping Nie

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Tibet Rhodiola Capsule; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03163615

2017002

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Tibet Rhodiola Capsule

Experimental group

Treatment:

Drug: Tibet Rhodiola Capsule

Placebo oral capsule

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule