Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
Status:
Completed
Trial end date:
2019-11-10
Target enrollment:
Participant gender:
Summary
Acute mountain sickness (AMS) is one of three syndromes of altitude illness. It is very
common when people venture over 2500 meters altitude. This illness is mainly induced by acute
exposure to low partial pressure of oxygen at high altitude that will cause a pathological
effect on humans. T89 capsule is a modernized industrialized traditional Chinese herbal
medicine. It is a botanical drug for oral use. In recent years, several literatures and
clinical studies have showed that oral administration of T89 may provide substantial benefits
in the prevention or alleviation of symptoms associated with acute mountain sickness (AMS),
including nausea, vomiting, headache, dizziness, fatigue, and sleep disturbance. Such effect
was also observed in a pilot clinical study recently conducted in Tibet in China.
This study is a prospective, double-blind, randomized, placebo-controlled phase 2 clinical
trial having three arms including T89 low-dose, T89 high-dose and a placebo controlled group.
People will be screened against the inclusion/exclusion criteria after informed consent
signed. Eligible subjects will be randomly assigned into one of three arms and instructed to
use T89 orally twice daily for 14 days (Days 1-14) before ascending, and 5 days after
ascending during the observation period (Days 15-19). The primary efficacy parameter is Lake
Louise Scoring System (LLSS) which will be evaluated by subject-self and principal
investigator in clinic.