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

NCT03552263 | Completed Phase 2 FDA Drug

• 1 other identifier: T89-30-AMS
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Mountain Sickness (AMS)

Keywords

Acute mountain sickness

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 16 morning (next morning of arrival at high altitude)

Secondary Outcomes (11)

• 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.

  Day 15 to Day 19 after initiation of treatment

• The total incidence of AMS evaluated by LLSS between T89 and Placebo groups.

  Day 15 to Day 19 after initiation of treatment

• The mean total Visual Analog Scales (VAS) scores of headache during rapid ascent (Days 15-19) between T89 and Placebo groups.

  Day 15 to Day 19 after initiation of treatment

• The exercise tolerance (maximum wattage achieved or watts/kg and difference in watts from sea level to altitude) during rapid ascent (Days 15-19) between T89 and Placebo groups.

  Day 15 to Day 19 after initiation of treatment

• The time from the foot of the mountain to onset of AMS between T89 and Placebo groups.

  Day 15 to Day 19 after initiation of treatment

Study Arms (3)

T89 low-dose group

EXPERIMENTAL

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.

Drug: T89 capsule; Drug: Placebo capsule

T89 high-dose group

EXPERIMENTAL

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

Drug: T89 capsule; Drug: Placebo capsule

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo capsule

Interventions

T89 capsule DRUG

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

T89 high-dose group; T89 low-dose group

Placebo capsule DRUG

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

Placebo group; T89 high-dose group; T89 low-dose group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers: ages 18 - 55 years old;
• Primary residence elevation of 1,000 ft 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, 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.
• Willing to participate voluntarily and to sign a written informed consent.

You may not qualify if:

• Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma;
• Subjects with clinically significant respiratory system disease, digestive disease, mental disease, metabolic disease, acute infection or anemia;
• Total LLSS self-assessment score and clinical assessment score is greater than 1 before ascending (Screening visit and Visit 1);
• Blood oxygen saturation (SpO2) \<95% at sea level;
• 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);
• Subjects with C reactive protein (CRP) \> ULN;
• Subjects with primary headache;
• 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;
• Contradictive to treatment of Danshen (Radix Salivae Miltiorrhizae, RSM) products;
• Women in pregnancy or lactation period;
• Substance abuse. Subjects with a recent history (within the last 2 years) of alcoholism or known drug dependence;
• Participation in any other clinical trial or on an investigational drug within 30 days prior to screening;
• A family member or relative of the study site staff;
• 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.

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Study Sites (1)

Hypoxia Research Lab, UCSF Parnassus Campus, S-256

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jeffrey W Sall, PhD, MD

  Department of Anesthesia and Perioperative Care, University of California, San Francisco, CA, U.S.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 11, 2018
• Study Start: June 7, 2018
• Primary Completion: October 20, 2019
• Study Completion: November 10, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)