Low dose group. 225 mg will be taken for duration of study

High dose group. This group will take a placebo for 12 days before going to altitude and will switch to 300 mg 2 days before being at altitude and will continue the 300 mg dose at altitude.

Acute Mountain Sickness

The study drug will be given orally for 14 days (Days 1-14) as pre-treatment before ascending, followed by a 5-day high-altitude treatment and observation period (Days 15-19).

T89 225 mg group

Placebo

For the pre-treatment period in the T89 300 mg group, subjects will take placebo on Days 1-12, and take T89 (300 mg, BID) on Days 13-19.

T89 300 mg group

UCSF

T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

A Double-blind, Randomized and Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

The self reported and clinical assessment of Lake Louise Scores will be compared between the placebo group and the T89 treatment group. The Lake Louise Scoring System (LLSS) is used to diagnose Acute Mountain sickness (AMS). The self reported LLSS asks a sojourner to altitude whether or not they have any of the hallmark signs of AMS and to rate the severity on a scale of 0-3, 0 being no symptoms and 3 being severe. These hallmark signs include Headache, Gastrointestinal symptoms, Fatigue and weakness, Dizziness and lightheadedness, and Difficulty sleeping. A Lake Louise score of 3-5 signifies mild AMS and >6 signifies severe AMS. The clinical assessment of the Lake Louise score includes checking sojourners for Ataxia, Edema and changes in mental status. These are also rated on a scale from 0 to 3 with 0 being asymptomatic and 3 being severe.

Jeffrey Sall

Associate Clinical Professor

University of California, San Francisco

Tasly Pharmaceuticals, Inc.

T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. Placebo capsule does not contain any amount of active substance.
Subjects in this group will use three T89 capsules and one Placebo capsule each time by oral administration twice daily for 19 days.

T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. Placebo capsule does not contain any amount of active substance.
Subjects in this group will use four Placebo capsules each time by oral administration twice daily for 12 days followed by using four T89 capsules each time by oral administration twice daily for 7 days

Placebo capsule does not contain any amount of active substance. Subjects in this group will use four Placebo capsules each time by oral administration twice daily for 19 days.

Acute Mountain Sickness (AMS)

T89 capsules (75mg), orally, twice daily.

T89 capsule

Placebo capsules (0mg), orally, twice daily.

Placebo capsule

Hypoxia Research Lab, UCSF Parnassus Campus, S-256

Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

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 morning of arrival at high altitude) is pre-specified as primary efficacy endpoint compared between T89 and Placebo groups.

LLSS assessments will be conducted twice per day: before breakfast and before sleep. The area under the curve (AUC) of LLSS total scores in the mean LLSS score-time profile during rapid ascent (Days 15-19) will be compared between T89 and Placebo groups.

The difference in total incidence of AMS (using LLSS to evaluate) will be compared between T89 and Placebo groups. AMS is defined as: (a) symptom of headache and LLSS self-assessment score ≥2, or (b) symptom of headache and any LLSS score ≥3.

Visual Analog Scales (VAS) scores [0-10]. VAS score of zero (0) represents no pain and VAS score of ten (10) represents the most severe pain (headache) ever.The higher VAS score, the worse pain. VAS scores assessments will be conducted twice per day: before breakfast and before sleep. The difference will be compared in the mean total VAS headache scores during and after rapid ascent from Day15 to Day19 between T89 and Placebo groups.

The exercise tolerance test will be performed on a computer controlled bicycle ergometer that increases the resistance in steps until the subject is exhausted and stops pedalling. The maximum wattage achieved or watts/kg and difference in watts from sea level to altitude will be compared over Day 15 to Day 19 after rapid ascent between T89 and Placebo groups.

Subjects will be recorded the time of the first onset of AMS during and after rapid ascent from Day 15 to Day 19. The difference will be compared in time to onset of AMS.

All dropped-out subjects will be recorded in terms of time of drop-out and reason (s). The "drop-out" over Day 15 to Day 19 as the result of at least one symptom of AMS is pre-defined as symptom-related drop-out, and the difference will be compared in the rate of symptom-related drop-out between T89 and Placebo groups.

All progressive diseases including, but not limited to, high altitude pulmonary adema (HAPE), high altitude cerebral adema (HACE) and severe AMS will be recorded in terms of the start and end time, severity, duration, emergency measurement and outcome over Day 15 to Day 19. The difference will be compared in the total incidence of progressive diseases between T89 and Placebo groups.

Blood oxygen saturation (SpO2) will be tested using a pulse oximetry and measured from the left index finger throughout the study. SpO2 will be tested four times daily by site staff before breakfast, before lunch, before dinner, and before sleep from Day 16 to Day 19. But for Day 15, SpO2 will be tested at sea level, arrival at altitude and before sleep. The difference will be compared in SpO2 from sea level to altitude over Day 15 to Day 19 after rapid ascent between T89 and Placebo groups.

All subjects will be stratified by comparing individual SpO2 value collected at the corresponding time of LLSS assessment with pooled median SpO2 value. The mean value of LLSS total scores for subjects with value of SpO2 less than pooled median value will be compared 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 recorded in vital signs from Days 15-19. They will be measured when subject is seated after a 5-min period of inactivity, and the blood pressure is recommended to examine on the same arm throughout the study. The difference will be compared in blood pressure from sea level to altitude over Day 15 to Day 19 after rapid ascent between T89 and Placebo groups.

Unit of heart rate is beats/minute. Heart rate will be recorded in vital signs from Days 15-19. They will be measured when subject is seated after a 5-min period of inactivity. The difference will be compared in heart rate from sea level to altitude over Day 15 to Day 19 after rapid ascent between T89 and Placebo groups.

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. 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). Specifically, for subjects in the T89 high-dose group, they will take placebo instead of T89 from Day 1 to Day 12, and take T89 on Days 13-14. The primary efficacy parameter is Lake Louise Scoring System (LLSS) which will be evaluated by subject-self and principal investigator in clinic. Other efficacy parameters include Visual Analog Scales (VAS), exercise tolerance, blood lactate, and blood oxygen saturation that will be performed at altitude.

borneol/главоболка

T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

Најкомплетната база на податоци за лековити билки поддржана од науката