Acute Mountain Sickness (AMS)Phase 3NCT04993729
Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
A Phase 3 study testing T89 capsule in people with Acute Mountain Sickness (AMS), run by Tasly Pharmaceuticals, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness (AMS)
- What is being tested?
- T89 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 853 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Jul 2021to 26 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers: ages 18 - 55 years old;
- Primary residence elevation of 2,461 ft (750m) or lower;
- Not ascending to altitude >10,000 ft within 4 months prior to screening;
- 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.
Who cannot join
- Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; uncontrolled hypertension with SBP>140 and or DBP>90 mmHg;
- Subjects with current and clinically significant respiratory system disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, acute infection or anemia, or who test positive for COVID-19 (COVID testing will be performed, not per study requirement, but in compliance with local law or policy, and subject with known positive for COVID-19 will be excluded).
- Total LLSS score (LLSS score) is ≥2 at any check point during screening period;
- Blood oxygen saturation (SpO2), preferably tested on the left-hand index finger, is less than 95% at screening visits;
- Subjects with abnormal renal or liver function with clinical significance (ALT or AST > 2×ULN, Creatinine > ULN) at screening visit;
- Subjects with CRP > ULN at screening visit;
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- Subjects with primary (migraine, tension-type headache, and cluster headache etc.) or secondary headaches (headache related to infection, vascular disease etc.) within one month at screening;
- Surgery or blood donation within 3 months prior to screening;
- On treatment of any medications (including any dietary supplements) except for birth control within 14 days prior to screening and throughout the study period;
- Smokers who had a habit of smoking during the last 4 months prior to the starting of screening;
- Contradictive to treatment of Danshen (Radix Saliva Miltiorrhize Bge., RSM) products;
- Women who are pregnant or lactating.
- Substance abuse. Subjects with a recent (within the last 6 months) history of substance abuse (alcohol, marijuana, or known drug dependence). Or subjects who have a positive urine substance test at screening;
- Participation in any other interventional clinical trial or on an investigational drug within 30 days prior to screening;
- A family member or relative of the study site staff;
- Any condition that, in the opinion of the investigator, is likely to prevent compliance with the study protocol, interfere with the assessment, or pose a safety concern if the subject participates in the study at screening.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610032
Tibet Autonomous Region People's Hospital
Lhasa, Tibet, 850000
United States1 site
Hypoxia Research Lab, UCSF Parnassus Campus, S-256
San Francisco, California, 94143
About this study
Official title: A Multicenter, Double-blind, Randomized and Placebo-controlled Pivotal Phase 3 Study to Evaluate the Safety and Efficacy of T89 in the Prevention and Treatment of Acute Mountain Sickness (AMS) After Rapid Ascent
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.
Read the detailed description
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.
- Conditions
- Acute Mountain Sickness (AMS)
- Being tested
- T89 capsule, Placebo capsule
- Keywords
- Acute Mountain Sickness
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T89 capsuleDrug
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 capsuleDrug
Placebo capsules, p.o. TID.
| Study group | Role | What they receive |
|---|---|---|
| T89 low-dose group | Experimental | Subjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days. Receives: Drug: T89 capsule; Drug: Placebo capsule |
| T89 high-dose group | Experimental | Subjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days. Receives: Drug: T89 capsule |
| Placebo group | Placebo comparator | 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. Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and day 4
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Screening day, days 2-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start21 Jul 2021
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain Sickness (AMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry H Sun, PhD, MD, Study chair, Tasly Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993729
- Sponsor's protocol ID
- T89-31-AMS
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized and Placebo-controlled Pivotal Phase 3 Study to Evaluate the Safety and Efficacy of T89 in the Prevention and Treatment of Acute Mountain Sickness (AMS) After Rapid Ascent
- ClinicalTrials.gov ID
- NCT04993729
- Acronym / sponsor ID
- T89-31-AMS
- Conditions
- Acute Mountain Sickness (AMS)
- Keywords
- Acute Mountain Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T89 low-dose group | Experimental | Drug: T89 capsule, Drug: Placebo capsuleSubjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days. |
| T89 high-dose group | Experimental | Drug: T89 capsuleSubjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days. |
| Placebo group | Placebo comparator | Drug: Placebo capsulePlacebo 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers: ages 18 - 55 years old;
- Primary residence elevation of 2,461 ft (750m) or lower;
- Not ascending to altitude >10,000 ft within 4 months prior to screening;
- 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.
Key exclusion criteria (16 listed)
- Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; uncontrolled hypertension with SBP>140 and or DBP>90 mmHg;
- Subjects with current and clinically significant respiratory system disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, acute infection or anemia, or who test positive for COVID-19 (COVID testing will be performed, not per study requirement, but in compliance with local law or policy, and subject with known positive for COVID-19 will be excluded).
- Total LLSS score (LLSS score) is ≥2 at any check point during screening period;
- Blood oxygen saturation (SpO2), preferably tested on the left-hand index finger, is less than 95% at screening visits;
- Subjects with abnormal renal or liver function with clinical significance (ALT or AST > 2×ULN, Creatinine > ULN) at screening visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T89 capsuleT89 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 | T89 high-dose group, T89 low-dose group |
| Placebo capsulePlacebo capsules, p.o. TID. | Drug | Placebo group, T89 low-dose group |
Primary outcome
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.
Time frame: Baseline and day 4
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.
11 secondary outcomes
The change of blood oxygen saturation levels (SpO2) at high altitude between T89 and placebo groups.
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.
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.
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.
Time frame: Days 4-5
The change of baseline corrected LLSS score at any given time points between T89 and placebo groups.
Time frame: Baseline and days 3-6
The change of total functional LLSS score at any given time points between T89 and placebo groups.
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.
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.
Time frame: Baseline and days 3 and 5
The change of the symptom-related AE drop-out rate between T89 and placebo groups.
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.
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.
Time frame: Screening day, days 2-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness
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HighCycle Study: Acetazolamide, High Altitude and Plasma Volume
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry H Sun, PhD, MD study chair
Tasly Pharmaceuticals, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T89 capsule in people with Acute Mountain Sickness (AMS), run by Tasly Pharmaceuticals, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups. (time frame: Baseline and day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.