EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jul 28, 2024

Keywords

ClinConnect Summary

The EleVation carE trial is a study designed to see if Suxiao Jiuxin Pills can help prevent Acute Mountain Sickness (AMS) in healthy adults who are going to high altitudes. AMS can cause headaches, nausea, and other uncomfortable symptoms when someone suddenly moves to a higher elevation. This trial will look at how safe the pills are and whether they work to reduce these symptoms.

To participate, you must be a healthy adult aged between 18 and 55, living at a low altitude (less than 500 meters), and not have traveled to a higher altitude (over 2500 meters) in the last six months. You also need to weigh at least 45 kg if you're female or 50 kg if you're male, and have a body mass index (BMI) within a specific range. Participants will receive more information about what to expect during the study, including any tests or assessments that will be done to check their health before and after exposure to high altitude. It's important to note that there are certain health conditions and recent activities that would exclude someone from participating, so a thorough screening will take place.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.