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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 is a Phase 2 study of Acute Mountain Sickness (AMS) that has completed, run by Tasly Pharmaceuticals. The registered enrollment target is 132 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03552263
The ClinicalTrials.gov registry entry for NCT03552263 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tasly Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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