What side effects are associated with this type of intervention?

Common treatments for altitude sickness, such as acetazolamide, dexamethasone, and ibuprofen, have known side effects. Acetazolamide can cause tingling in the hands and feet, frequent urination, and a metallic taste. Dexamethasone may lead to increased blood sugar levels, mood changes, and difficulty sleeping. Ibuprofen, often used for pain and inflammation, can cause gastrointestinal issues like stomach pain, heartburn, and nausea. In the T89 trial, the safety and efficacy of T89 were evaluated, but specific side effects were not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved acetazolamide and dexamethasone for the prevention and treatment of altitude sickness. Acetazolamide works by acidifying the blood, which stimulates breathing and helps increase oxygen levels. Dexamethasone is a corticosteroid that reduces inflammation and cerebral edema associated with altitude sickness. These medications are commonly used to prevent and manage symptoms of acute mountain sickness (AMS) during rapid ascent.

What other types of research exist?

Based on the provided context, there are no direct alternatives to T89 specifically for altitude sickness. However, compounds like BAY 87-2243, which inhibits hypoxia-induced gene activation, might be considered for further investigation due to their potential relevance in managing hypoxia-related conditions.

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Herbal Medicine

T89 for Altitude Sickness

Phase 3

Waitlist Available

Led By Jeffrey W Sall, PhD, MD

Research Sponsored by Tasly Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers: ages 18 - 55 years old

Be between 18 and 65 years old

Must not have

Subjects with current and clinically significant respiratory system disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, acute infection or anemia, or who test positive for COVID-19 (COVID testing will be performed, not per study requirement, but in compliance with local law or policy, and subject with known positive for COVID-19 will be excluded)

Contradictive to treatment of Danshen (Radix Saliva Miltiorrhize Bge., RSM) products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 4-5

Awards & highlights

Pivotal Trial

Summary

This trial tests T89, a herbal pill, to see if it can prevent or reduce symptoms of Acute Mountain Sickness in people going to high altitudes. The pill helps the body handle low oxygen levels better. T89 (Dantonic) is a modern herbal medicine currently used in Chinese hospitals for the management of heart disease.

Who is the study for?

Healthy adults aged 18-55, living below 2,461 ft elevation, who haven't been to high altitudes recently. Women must test negative for pregnancy and use contraception. Excludes those with recent headaches, abnormal blood tests, on certain meds or supplements (except birth control), smokers, substance abusers, and anyone with significant health issues.

What is being tested?

This phase III trial is testing T89 capsules against placebo to see if they can prevent or relieve symptoms of Acute Mountain Sickness after quickly going up in altitude. Participants are randomly assigned to either the T89 treatment or a dummy pill without knowing which one they're getting.

What are the potential side effects?

While the trial primarily aims to assess safety and efficacy of T89 for Altitude Sickness prevention and symptom relief, potential side effects are not detailed here but will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old and healthy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have significant health issues like lung, liver, kidney diseases, or COVID-19.

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I cannot take Danshen products due to adverse reactions.

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My liver or kidney tests are not normal.

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I have a history of heart, stroke, or asthma issues, or my blood pressure is often above 140/90.

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I have not had surgery or donated blood in the last 3 months.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 4-5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 4-5

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 4-5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.

Secondary study objectives

Accumulated incidence rate of subjects who underwent any rescue activity in transit and after ascending between T89 and placebo groups.

The change in total incidence of LLSS score ≥5 on Day 4 morning between T89 and placebo groups.

The change of baseline corrected LLSS score at any given time points between T89 and placebo groups.

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: T89 low-dose groupExperimental Treatment2 Interventions

Subjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days.

Group II: T89 high-dose groupExperimental Treatment1 Intervention

Subjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days.

Group III: Placebo groupPlacebo Group1 Intervention

Placebo capsule does not contain any amount of active substance. Subjects in this group will take four placebo capsules each time by oral administration three times daily for 5 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

T89 capsule

2018

Completed Phase 3

~990

Placebo capsule

2015

Completed Phase 4

~5340

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for altitude sickness include acetazolamide, dexamethasone, and supplemental oxygen. Acetazolamide induces mild metabolic acidosis, stimulating breathing and improving oxygenation. Dexamethasone reduces inflammation and cerebral edema. Supplemental oxygen increases the amount of oxygen available to the body. These treatments are essential for altitude sickness patients as they address the primary issue of inadequate oxygen supply, preventing severe complications such as high-altitude cerebral edema (HACE) and high-altitude pulmonary edema (HAPE).

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