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Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

NCT03552263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-11-13

No results posted yet for this study

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.

Conditions

  • Acute Mountain Sickness (AMS)

Interventions

DRUG

T89 capsule

T89 capsules (75mg), orally, twice daily.

DRUG

Placebo capsule

Placebo capsules (0mg), orally, twice daily.

Sponsors & Collaborators

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey W Sall, PhD, MD · Department of Anesthesia and Perioperative Care, University of California, San Francisco, CA, U.S.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2019-10-20
Completion
2019-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03552263 on ClinicalTrials.gov