Last reviewed · How we verify
Safety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial (EVEREST)
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 volunteers, and its influences on physiological indicators before and after high altitude exposure.
Details
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 168 |
| Start date | 2024-08 |
| Completion | 2025-09 |
Conditions
- Acute Mountain Sickness
Interventions
- Suxiao Jiuxin Pill
- Placebo
Primary outcomes
- Incidence rate of AMS assessed by LLS system on the next morning of arrival day at high altitude between Suxiao Jiuxin Pill and Placebo groups. — The next morning of arrival day at high altitude
AMS was defined as LLS score ≥ 3 with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness. The difference in incidence rate of AMS on the next morning of arrival day at high altitude is pre-specified as primary efficacy endpoint between Suxiao Jiuxin Pill and Placebo groups.