Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03552263 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
A Phase 2 study of Acute Mountain Sickness (AMS), sponsored by Tasly Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT03552263: Completed Phase 2 study of Acute Mountain Sickness (AMS), sponsored by Tasly Pharmaceuticals.
NCT03552263 is a Phase 2 study of Acute Mountain Sickness (AMS) that has completed, run by Tasly Pharmaceuticals. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03552263, a Phase 2 study of Acute Mountain Sickness (AMS), has completed, sponsored by Tasly Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Lake Louise Scoring System (LLSS) self-assessment score \[0-15\]. Lake Louise Scoring System (LLSS) clinical assessment score \[0-10\]. Lake Louise Scoring System (LLSS) self-and clinical assessment score \[0-25\].The higher LLSS score, the worse symptoms of AMS. The Lake Louise Scoring System (LLSS) will be assessed by subject-self and clinic staff (principal investigator or sub- investigator) twice daily from Day 15 to Day 19. And the difference in LLSS total scores on Day 16 morning (next mor
Conditions Studied
Interventions
- DRUG T89 capsule
- DRUG Placebo capsule
Study Locations (1)
California
- Hypoxia Research Lab, UCSF Parnassus Campus, S-256 - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2019-11-10 |
| Phase | Phase 2 |
What the finished NCT03552263 record still lists
NCT03552263 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 1 condition, with Acute Mountain Sickness (AMS) appearing as the primary indexed condition, and to 2 interventions - of which T89 capsule is the first listed.
NCT03552263 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03552263 about?
NCT03552263 is a clinical study titled "Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)". 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 capsu...
What is the current status of trial NCT03552263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2018-06-07. Estimated completion is 2019-11-10.
What conditions does trial NCT03552263 study?
This clinical trial studies the following conditions: Acute Mountain Sickness (AMS).
What interventions are being tested in trial NCT03552263?
The interventions under investigation include: T89 capsule (DRUG), Placebo capsule (DRUG).
Who is sponsoring clinical trial NCT03552263?
This trial is sponsored by Tasly Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03552263 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03552263's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI