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

NCT04993729 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 853

Last updated 2024-08-13

No results posted yet for this study

Summary

The specific aim of this double blind, randomized phase III trial is to evaluate the safety and efficacy of T89 in preventing Acute Mountain Sickness (AMS) and relieving the symptoms of AMS after rapid ascent.

Conditions

  • Acute Mountain Sickness (AMS)

Interventions

DRUG

T89 capsule

T89 capsule (trade name Dantonic®) is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. T89 capsules, p.o. TID.

DRUG

Placebo capsule

Placebo capsules, p.o. TID.

Sponsors & Collaborators

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Henry H Sun, PhD, MD · Tasly Pharmaceuticals, Inc.

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
2021-07-21
Primary Completion
2023-05-26
Completion
2023-05-26
FDA Drug
Yes

Countries

  • United States
  • China

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 NCT04993729 on ClinicalTrials.gov