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Herbal Medicine
T89 for Altitude Sickness
Phase 3
Recruiting
Led By Jeffrey W Sall, PhD, MD
Research Sponsored by Tasly Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy volunteers: ages 18 - 55 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 4-5
Awards & highlights
Study Summary
This trial is testing a drug called T89 to see if it can help prevent or reduce the symptoms of Acute Mountain Sickness (AMS).
Who is the study for?
Healthy adults aged 18-55, living below 2,461 ft elevation, who haven't been to high altitudes recently. Women must test negative for pregnancy and use contraception. Excludes those with recent headaches, abnormal blood tests, on certain meds or supplements (except birth control), smokers, substance abusers, and anyone with significant health issues.Check my eligibility
What is being tested?
This phase III trial is testing T89 capsules against placebo to see if they can prevent or relieve symptoms of Acute Mountain Sickness after quickly going up in altitude. Participants are randomly assigned to either the T89 treatment or a dummy pill without knowing which one they're getting.See study design
What are the potential side effects?
While the trial primarily aims to assess safety and efficacy of T89 for Altitude Sickness prevention and symptom relief, potential side effects are not detailed here but will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old and healthy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 4-5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 4-5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.
Secondary outcome measures
Accumulated incidence rate of subjects who underwent any rescue activity in transit and after ascending between T89 and placebo groups.
The change in total incidence of LLSS score ≥5 on Day 4 morning between T89 and placebo groups.
The change of baseline corrected LLSS score at any given time points between T89 and placebo groups.
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: T89 low-dose groupExperimental Treatment2 Interventions
Subjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days.
Group II: T89 high-dose groupExperimental Treatment1 Intervention
Subjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days.
Group III: Placebo groupPlacebo Group1 Intervention
Placebo capsule does not contain any amount of active substance. Subjects in this group will take four placebo capsules each time by oral administration three times daily for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T89 capsule
2018
Completed Phase 2
~140
Placebo capsule
2015
Completed Phase 4
~5270
Find a Location
Who is running the clinical trial?
Tasly Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
4,729 Total Patients Enrolled
2 Trials studying Altitude Sickness
190 Patients Enrolled for Altitude Sickness
Jeffrey W Sall, PhD, MDPrincipal InvestigatorDepartment of Anesthesia and Perioperative Care, University of California, San Francisco, CA, U.S.
1 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Altitude Sickness
132 Patients Enrolled for Altitude Sickness
Henry H Sun, PhD, MDStudy ChairTasly Pharmaceuticals, Inc.
1 Previous Clinical Trials
765 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have significant health issues like lung, liver, kidney diseases, or COVID-19.You have smoked in the last 4 months before the screening starts.I am between 18 and 55 years old and healthy.You have a history of using alcohol, marijuana, or drugs in the last 6 months, or if you test positive for these substances during screening.I cannot take Danshen products due to adverse reactions.I have had headaches, like migraines or tension headaches, in the last month.Your blood oxygen level, tested on your left-hand index finger, is less than 95% at screening visits.I am not on any medications or supplements, except for birth control.Your CRP level is higher than the normal range at the screening visit.My liver or kidney tests are not normal.I have a history of heart, stroke, or asthma issues, or my blood pressure is often above 140/90.I have not had surgery or donated blood in the last 3 months.I am not pregnant or breastfeeding.You live at an altitude of 2,461 feet (750 meters) or less.You have not gone to a place higher than 10,000 feet in the last 4 months before screening.Your LLSS score is 2 or higher at any time during the screening period.
Research Study Groups:
This trial has the following groups:- Group 1: T89 low-dose group
- Group 2: T89 high-dose group
- Group 3: Placebo group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators seeking more test subjects for this experiment?
"Yes, this is an ongoing trial that is currently looking for participants. The listing was first posted on July 21st, 2021 and the most recent update occurred on August 3rd, 2021."
Answered by AI
Which patients does this trial look for?
"This study is looking for 846 participants who are currently experiencing the effects of high altitude. To be eligible, individuals must be between 18-55 years old and live at an elevation of 2,461 feet (750m) or lower. In addition, females of childbearing potential must have a negative pregnancy test and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception from the time of the screening visit and throughout the study period;, Willing to participate voluntarily and sign a written informed consent.."
Answered by AI
Does this research project allow for subjects who are over 30 years old?
"The age parameters for this clinical trial are that patients must be aged 18 or over, and cannot be older than 55."
Answered by AI
Has the T89 capsule received FDA approval?
"T89 capsule scores a 3 for safety on our 1-3 scale at Power. This is due to the fact that T89 is in Phase 3 trials, signifying that there is some evidence of efficacy as well as multiple rounds of data supporting its safety."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Hypoxia Research Lab, UCSF Parnassus Campus, S-256
What portion of applicants met pre-screening criteria?
Did not meet criteria
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