A Phase 3 interventional study of T89 capsule and Placebo capsule in Acute Mountain Sickness (AMS), sponsored by Tasly Pharmaceuticals, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Tasly Pharmaceuticals, Inc. (part of China Resources Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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.
Acute mountain sickness (AMS) is a common ailment in people venturing over 2,500 meters altitude. It is a pathological effect of high altitude on humans, caused by acute exposure to low partial pressure of oxygen at high altitude. It presents with a cluster of nonspecific symptoms including headache and one of the following: gastrointestinal symptoms, fatigue and/or weakness, dizziness/ lightheadedness or difficulty sleeping.
T89 capsule is a modernized industrialized version of a traditional Chinese herbal medicine. It is a botanical drug product for oral use. Previous clinical studies showed T89 has substantial benefits in the prevention or amelioration of symptoms associated with acute mountain sickness (AMS).This is double-blind, randomized, placebo controlled pivotal phase 3 study. After informed consent is obtained, eligible subjects will be randomized to one of the 3 study groups (T89 high dose, T89 low dose and placebo control). The study drug will be given orally for 5 days (2 days at sea level and 3 days at high altitude). The clinical assessment of Lake Louise Scoring System (LLSS), blood oxygen saturation, the exercise tolerance, blood pressure and heart rate will be performed at sea level and altitude. A total of 846 subjects will be enrolled with 282 subjects in each treatment arm, and a minimum of 756 subjects are expected to complete the study.
216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.
This study's enrollment of 853 is above the median of 34 across 178 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →Tasly Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
First submitted before Tasly Pharmaceuticals, Inc. became part of China Resources Pharmaceutical Group Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days.
Drug: T89 capsule · Drug: Placebo capsule
Subjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days.
Drug: T89 capsule
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.
Drug: Placebo 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.
Placebo capsules, p.o. TID.
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.
2018 Lake Louise Scoring System (LLSS) score \[0-12\] will be used in this primary outcome assessment. The higher LLSS scores mean the worse symptoms of AMS. Baseline will be the average of LLSS scores on Day 2 and the one on Day 3 before breakfast.
Time frame: Baseline and day 4
The change of blood oxygen saturation levels (SpO2) at high altitude between T89 and placebo groups.
Blood oxygen saturation (SpO2) will be measured by pulse oximeter at sea level (on screening day, Day 2 and Day 3 morning) and at high altitude (Day 3 after arriving and Day 4-Day 6).
Time frame: Baseline and days 3-6
The change of the area under the curve (AUC) of baseline corrected LLSS score-time profile between T89 and placebo groups.
AUC of based corrected LLSS score-time curve during altitude stay will be compared between T89 and placebo groups.
Time frame: Baseline and days 3-6
The change in total incidence of LLSS score ≥5 on Day 4 morning between T89 and placebo groups.
Total incidence of LLSS score ≥5 will be recorded on Day 4 morning. The difference between T89 and placebo groups will be compared.
Time frame: Day 4 morning
The change of percentage reduction of the daily total LLSS score from Day 4 to Day 5 between T89 and placebo groups.
Proportional reduction of the daily total LLSS score from Day 4 to Day 5 at high altitude will be compared between T89 and placebo groups.
Time frame: Days 4-5
The change of baseline corrected LLSS score at any given time points between T89 and placebo groups.
2018 Lake Louise Scoring System (LLSS) score \[0-12\] will be used in this primary outcome assessment. The higher LLSS scores mean the worse symptoms of AMS. Baseline corrected LLSS score will be assessed at every time points at high altitude from Day 3 to Day 6.
Time frame: Baseline and days 3-6
The change of total functional LLSS score at any given time points between T89 and placebo groups.
The functional score \[0-3\] will be self-reported using the 1993 Lake Louise Acute Mountain Sickness Score System to evaluate how did AMS symptoms affect subjects' activities, if they have AMS symptoms. The higher functional scores mean the worse symptoms of AMS.
Time frame: Baseline and days 3-6
Accumulated incidence rate of subjects who underwent any rescue activity in transit and after ascending between T89 and placebo groups.
The total incidence of subjects who received rescue medicine, oxygen or descent to lower level will be recorded in transit and after arriving high altitude.
Time frame: Days 3-6
The change of exercise tolerance at high altitude (on Day 3 after arriving and Day 5, respectively) from those of at sea level baseline between T89 and placebo groups.
Exercise tolerance test will be performed on bicycle ergometer.
Time frame: Baseline and days 3 and 5
The change of the symptom-related AE drop-out rate between T89 and placebo groups.
The symptom-related AE drop-out rate is proportion of participants who dropped out study because of adverse event.
Time frame: Days 3-6
The change of blood pressure (mmHg) during at high altitude from those of at sea level baseline on Day 1 (prior to the first dose administration) between T89 and placebo groups.
Unit of blood pressure is mmHg. Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded. Blood pressure will be measured at each applicable visit during the whole study period (screening day, Day 2-Day 6).
Time frame: Screening day, days 2-6
The change of heart rate (beats/minute) at high altitude from those of at sea level baseline on Day 1 (prior to the first dose administration) between T89 and placebo groups.
Unit of heart rate is beats/minute. Heart rate will be measured at each applicable visit during the whole study period (screening day, Day 2-Day 6).
Time frame: Screening day, days 2-6
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: T89