Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
Condition: Acute Mountain Sickness (AMS)
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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. It presents a syndrome characterized by a collection of nonspecific
      symptoms, including headache and one of the following: gastrointestinal symptoms, fatigue
      and/or weakness, dizziness/light headedness or difficulty sleeping. Severity and incidence of
      these symptoms depend on the speed of ascent, altitude, duration of altitude exposure,
      physical exertion, and inherent genetic susceptibility.

      T89 capsule is a modernized industrialized traditional Chinese herbal medicine. It is a
      botanical drug for oral use. The active substance is the water extract of Danshen (Radix
      Salivae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN). T89 capsule also contains
      Bingpian (Borneol) which may promote absorption of the active substance. 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). Specifically, for subjects in the T89
      high-dose group, they will take placebo instead of T89 from Day 1 to Day 12, and take T89 on
      Days 13-14. The primary efficacy parameter is Lake Louise Scoring System (LLSS) which will be
      evaluated by subject-self and principal investigator in clinic. Other efficacy parameters
      include Visual Analog Scales (VAS), exercise tolerance, blood lactate, and blood oxygen
      saturation that will be performed at altitude. The primary efficacy endpoint is the
      difference in LLSS total scores on Day 16 morning (12 hours after arrival at high altitude)
      compared between T89 and Placebo group. A total of 120 subjects will be enrolled with
      approximately 40 subjects in each arm, and a minimum of 100 subjects are expected to complete
      the study.
    

Intervention name(s): T89 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): T89 capsules (75mg), orally, twice daily.; Placebo capsules (0mg), orally, twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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. 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). Specifically, for subjects in the T89 high-dose group, they will take placebo instead of T89 from Day 1 to Day 12, and take T89 on Days 13-14. The primary efficacy parameter is Lake Louise Scoring System (LLSS) which will be evaluated by subject-self and principal investigator in clinic. Other efficacy parameters include Visual Analog Scales (VAS), exercise tolerance, blood lactate, and blood oxygen saturation that will be performed at altitude.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute mountain sickness