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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed Description

      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. It presents a syndrome characterized by a collection of nonspecific
      symptoms, including headache and one of the following: gastrointestinal symptoms, fatigue
      and/or weakness, dizziness/light headedness or difficulty sleeping. Severity and incidence of
      these symptoms depend on the speed of ascent, altitude, duration of altitude exposure,
      physical exertion, and inherent genetic susceptibility.

      T89 capsule is a modernized industrialized traditional Chinese herbal medicine. It is a
      botanical drug for oral use. The active substance is the water extract of Danshen (Radix
      Salivae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN). T89 capsule also contains
      Bingpian (Borneol) which may promote absorption of the active substance. 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). 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. The primary efficacy endpoint is the
      difference in LLSS total scores on Day 16 morning (12 hours after arrival at high altitude)
      compared between T89 and Placebo group. A total of 120 subjects will be enrolled with
      approximately 40 subjects in each arm, and a minimum of 100 subjects are expected to complete
      the study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The LLSS self- and clinical assessments score on Day 16 morning(next morning of arrival at high altitude) between T89 and Placebo groups.

Secondary Outcome

 The area under the curve (AUC) of LLSS self- and clinical assessments score in the mean LLSS score-time profile during rapid ascent (Days 15-19) between T89 and Placebo groups.

Condition

Acute Mountain Sickness (AMS)

Intervention

T89 capsule

Study Arms / Comparison Groups

 T89 low-dose group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

132

Start Date

June 7, 2018

Completion Date

November 10, 2019

Primary Completion Date

October 20, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy volunteers: ages 18 - 55 years old;

          2. Primary residence elevation of 1,000 ft or lower;

          3. Not ascending to altitude >10,000 ft within 4 months prior to screening;

          4. Females of childbearing potential must have a negative pregnancy test, not be breast
             feeding 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.

          5. Willing to participate voluntarily and to sign a written informed consent.

        Exclusion Criteria:

          1. Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma;

          2. Subjects with clinically significant respiratory system disease, digestive disease,
             mental disease, metabolic disease, acute infection or anemia;

          3. Total LLSS self-assessment score and clinical assessment score is greater than 1
             before ascending (Screening visit and Visit 1);

          4. Blood oxygen saturation (SpO2) <95% at sea level;

          5. Subjects with abnormal renal or liver function with clinical significance (alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) > 2×upper limits of
             normal(ULN), Creatinine> ULN);

          6. Subjects with C reactive protein (CRP) > ULN;

          7. Subjects with primary headache;

          8. Surgery or blood donation within 3 months prior to screening;

          9. On treatment of any medications (including any dietary supplements)except for birth
             control within 14 days prior to screening and throughout the study period;

         10. Contradictive to treatment of Danshen (Radix Salivae Miltiorrhizae, RSM) products;

         11. Women in pregnancy or lactation period;

         12. Substance abuse. Subjects with a recent history (within the last 2 years) of
             alcoholism or known drug dependence;

         13. Participation in any other clinical trial or on an investigational drug within 30 days
             prior to screening;

         14. A family member or relative of the study site staff;

         15. Any other 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.
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jeffrey W Sall, PhD, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03552263

Organization ID

T89-30-AMS


Responsible Party

Sponsor

Study Sponsor

Tasly Pharmaceuticals, Inc.


Study Sponsor

Jeffrey W Sall, PhD, MD, Principal Investigator, Department of Anesthesia and Perioperative Care, University of California, San Francisco, CA, U.S.


Verification Date

November 2019