Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT06531161
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06531161
Study Brief:
Protocol Section:
NCT06531161