Status:
NOT_YET_RECRUITING
EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
Conditions:
Acute Mountain Sickness
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this randomized, controlled trial is to evaluate the safety and efficacy of Suxiao Jiuxin Pills for prevention of acute mountain sickness (AMS) after high altitude exposure in healthy volun...
Detailed Description
Acute altitude illness refers to a group of clinical symptoms that occur when travelers are exposed to high altitude in a short period of time, due to the body's incomplete or dysregulated adaptation ...
Eligibility Criteria
Inclusion
- Healthy volunteers, aged 18-55 years old (including boundary values);
- Female volunteers weighing ≥45.0 kg and male volunteers weighing ≥50.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2 (including boundary values) (BMI=weight kg/height m2);
- Primary residence at an altitude of \<500 meters above sea level;
- Not ascending to an altitude \>2500 meters in the 6 months prior to the screening period;
- Voluntary participation with written informed consent.
Exclusion
- Subjects with previous severe high altitude sickness such as high altitude heart disease, high altitude pulmonary edema, high altitude cerebral edema, and high altitude erythrocytosis;
- Subjects with established cardiovascular or cerebrovascular disease or uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg at screening);
- Subjects with clinically significant respiratory disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, anemia, or acute infection;
- Subjects with primary headache (migraine, tension headache, cluster headache, etc.) or secondary headache (headache associated with infection, cerebrovascular, etc.) within 1 month prior to screening;
- Subjects with insomnia, anxiety, depression or a history of motion sickness or airplane sickness;
- Subjects with Lake Louise Score ≥ 2 at screening;
- Subjects with left index finger oxygen saturation \<95% at screening;
- Subjects with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of the normal range, or creatinine \> upper limit of the normal range at screening;
- Subjects with hypersensitive C-reactive protein \> upper limit of normal range at screening;
- Subjects with history of surgery or blood donation within 3 months prior to screening;
- Subjects with any medication or non-pharmacological intervention (including dietary supplements) to prevent or treat acute mountain sickness within 14 days prior to screening;
- Smoking ≥20 cigarettes per day within 3 months prior to screening;
- Contraindications to the use of Suxiao Jiuxin Pill, such as allergies;
- Women who are pregnant, breastfeeding, or have a positive pregnancy test (human chorionic gonadotropin test);
- Alcohol abuse \[more than 28 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL spirit with 40% alcohol by volume, or 150 mL of wine)\] or substance abuse within 6 months prior to screening;
- Participation in another interventional clinical study within 3 months prior to screening;
- Other conditions, in the opinion of the investigators, make participation in this study inappropriate.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06531161
Start Date
August 1 2024
End Date
September 1 2025
Last Update
August 12 2024
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