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

NCT ID: NCT03163615

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-17
• Study Completion Date: 2018-05-30

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tibet Rhodiola Capsule

Group Type: EXPERIMENTAL

Tibet Rhodiola Capsule

Intervention Type: DRUG

4 capsules, po, from admission up to 84 days

Placebo oral capsule

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

4 capsules, po, from admission up to 84 days

Interventions

Tibet Rhodiola Capsule

4 capsules, po, from admission up to 84 days

Intervention Type: DRUG

Placebo oral capsule

4 capsules, po, from admission up to 84 days

Intervention Type: DRUG

Other Intervention Names

Xueyu Hongjingtian Huoli Jiaonang

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shao-Ping Nie

OTHER

Sponsor Role: lead

Responsible Party

Shao-Ping Nie

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shao-Ping Nie, MD, PhD

Role: primary

spnie@126.com

86-10-84005256

Other Identifiers

2017002

Identifier Type: -

Identifier Source: org_study_id