EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill

NCT06531161 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SXJX-AMS-02
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this randomized, controlled trial is to evaluate the safety and efficacy of Suxiao Jiuxin Pills for prevention of acute mountain sickness (AMS) after high altitude exposure in healthy volunteers, and its influences on physiological indicators before and after high altitude exposure.

Conditions

Acute Mountain Sickness

Keywords

Acute Mountain Sickness; Suxiao Jiuxin Pill; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Incidence rate of AMS assessed by LLS system on the next morning of arrival day at high altitude between Suxiao Jiuxin Pill and Placebo groups.

  AMS was defined as LLS score ≥ 3 with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness. The difference in incidence rate of AMS on the next morning of arrival day at high altitude is pre-specified as primary efficacy endpoint between Suxiao Jiuxin Pill and Placebo groups.

  The next morning of arrival day at high altitude

Secondary Outcomes (9)

• Incidence rate of AMS assessed by LLS system after arrival at high altitude between Suxiao Jiuxin Pill and Placebo groups.

  Arrival day to Day 3 after high altitude exposure

• Baseline-corrected LLS after high altitude exposure between Suxiao Jiuxin Pill and Placebo groups.

  Day 4 at sea level to Day 3 after high altitude exposure

• Area under the curve (AUC) of LLS in the mean LLS score-time profile after arrival between Suxiao Jiuxin Pill and Placebo groups.

  Arrival day to Day 3 after high altitude exposure

• Incidence rate of moderate and above AMS on the next morning of arrival at high altitude between Suxiao Jiuxin Pill and Placebo groups.

  The next morning of arrival day at high altitude

• Mean AMS Clinical Functional Score after arrival between Suxiao Jiuxin Pill and Placebo groups.

  Arrival day to Day 3 after high altitude exposure

Other Outcomes (6)

• Change of blood pressure and heart rate at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.

  Baseline, Day 4 at sea level, arrival day, Day 3 after high altitude exposure

• Change of brain natriuretic peptide (BNP) at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.

  Baseline, the next day after arrival, Day 3 after arrival

• Change of pulmonary artery systolic pressure estimated by echocardiography at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.

  Baseline, the next day after arrival, Day 3 after arrival

Study Arms (2)

Experimental: Suxiao Jiuxin Pill group

EXPERIMENTAL

Participants who are randomly assigned to Suxiao Jiuxin Pill group will receive Suxiao Jiuxin Pills (6 pills per time, 3 times a day, taken sublingually) for 4 days at sea level and another 3 days at high altitude.

Drug: Suxiao Jiuxin Pill

Placebo: Placebo group

PLACEBO COMPARATOR

Participants who are randomly assigned to Placebo group will receive placebo (6 pills per time, 3 times a day, taken sublingually) for 4 days at sea level and another 3 days at high altitude.

Drug: Placebo

Interventions

Suxiao Jiuxin Pill DRUG

Suxiao Jiuxin Pill is a traditional Chinese medicine compound composed of Ligusticum Wallichii and Borneo Camphorwood, and its clinical safety has been confirmed. Traditional Chinese medicine theory believes that Suxiao Jiuxin Pill has the effects of promoting qi and blood circulation, removing blood stasis and relieving pain, which may help alleviate symptoms of AMS.

Experimental: Suxiao Jiuxin Pill group

Placebo DRUG

Placebo is made of less than 10% of the amount of Suxiao Jiuxin Pill, with similar dosage, odor, and taste.

Placebo: Placebo group

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers, aged 18-55 years old (including boundary values);
• Female volunteers weighing ≥45.0 kg and male volunteers weighing ≥50.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2 (including boundary values) (BMI=weight kg/height m2);
• Primary residence at an altitude of \<500 meters above sea level;
• Not ascending to an altitude \>2500 meters in the 6 months prior to the screening period;
• Voluntary participation with written informed consent.

You may not qualify if:

• Subjects with previous severe high altitude sickness such as high altitude heart disease, high altitude pulmonary edema, high altitude cerebral edema, and high altitude erythrocytosis;
• Subjects with established cardiovascular or cerebrovascular disease or uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg at screening);
• Subjects with clinically significant respiratory disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, anemia, or acute infection;
• Subjects with primary headache (migraine, tension headache, cluster headache, etc.) or secondary headache (headache associated with infection, cerebrovascular, etc.) within 1 month prior to screening;
• Subjects with insomnia, anxiety, depression or a history of motion sickness or airplane sickness;
• Subjects with Lake Louise Score ≥ 2 at screening;
• Subjects with left index finger oxygen saturation \<95% at screening;
• Subjects with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of the normal range, or creatinine \> upper limit of the normal range at screening;
• Subjects with hypersensitive C-reactive protein \> upper limit of normal range at screening;
• Subjects with history of surgery or blood donation within 3 months prior to screening;
• Subjects with any medication or non-pharmacological intervention (including dietary supplements) to prevent or treat acute mountain sickness within 14 days prior to screening;
• Smoking ≥20 cigarettes per day within 3 months prior to screening;
• Contraindications to the use of Suxiao Jiuxin Pill, such as allergies;
• Women who are pregnant, breastfeeding, or have a positive pregnancy test (human chorionic gonadotropin test);
• Alcohol abuse \[more than 28 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL spirit with 40% alcohol by volume, or 150 mL of wine)\] or substance abuse within 6 months prior to screening;

Sponsors & Collaborators

• Peking University First Hospital: lead
• Tibet Autonomous Region Hospital of Traditional Tibetan Medicine: collaborator

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Yong Huo, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Yan Zhang, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiyin Li, M.D.

CONTACT

010-83575389; kaiyin0313@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, care providers, investigators, and outcome assessors will be blinded throughout the clinical trial. To ensure blindness, the experimental drug and placebo will be similar in dosage, odor, and taste. Suxiao Jiuxin Pill and placebo will be repackaged and distributed according to standardized procedures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share