Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

Study Overview
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Brief Summary
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This trial is aimed to evaluate the effects of Wu Zhu Yu Tang on the prevention of Acute Mountain Sickness(AMS).

Detailed Description
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This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription Wu Zhu Yu Tang can prevent Acute Mountain Sickness(AMS) (2) Wu Zhu Yu Tang can prevent AMS especially for Yang-Xu body constitution. We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the Body Constitution Questionnaire BCQ in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.

Official Title
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Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

Conditions
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Acute Mountain Sickness (AMS)

Intervention / Treatment
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* Drug: Chinese Medicine
* Drug: Acetalozamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults Exclusion Criteria: Chronic disease: cardiovascular disease, psychological disease, anemia, migraine. long-term use of the following materials: Chinese herbs, steroid, antibiotics. altitude acclimation: have been to mountain over 2000m in the past 1 month. Pregnancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Medicine<br>The participators in this arm will take 2g (powder in capsule) of Wu Zhu Yu Tang or placebo orally three times in the first day and one time in the second day. | Drug: Chinese Medicine<br>* The participators in this arm will take 2g (powder in capsule) of Wu Zhu Yu Tang or placebo orally three times in the first day and one time in the second day.<br>* Other names: Wu Zhu Yu Tang;|
| Placebo Comparator: Acetazolamide<br>If the participators have the history of AMS, he/she will be randomized to take Wu Zhu Yu Tang plus placebo of Acetalozamide or Acetalozamide plus placebo of Wu Zhu Yu Tang. | Drug: Chinese Medicine<br>* The participators in this arm will take 2g (powder in capsule) of Wu Zhu Yu Tang or placebo orally three times in the first day and one time in the second day.<br>* Other names: Wu Zhu Yu Tang;Drug: Acetalozamide<br>* If the participators have the history of AMS, he/she will be randomized to take Wu Zhu Yu Tang plus placebo of Acetalozamide or Acetalozamide plus placebo of Wu Zhu Yu Tang.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache) | The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The Lake Louise score will measure before and after hiking. | The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of blood pressure will be measured before and after hiking. | Blood pressure will be measured before and after the hiking. | 
| Heart rate | The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of heart rate will be measured before and after hiking. | Heart rate will be measured before and after the hiking. | 
| Arterial oxygen saturation | Description: The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of arterial oxygen saturation will be measured before and after hiking. | Arterial oxygen saturation will be measured before and after the hiking. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking