Acute Mountain Sickness (AMS)
Conditions
Keywords
High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking
Brief summary
This trial is aimed to evaluate the effects of Wu Zhu Yu Tang on the prevention of Acute Mountain Sickness(AMS).
Detailed description
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.
Interventions
DRUGChinese Medicine
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.
DRUGAcetalozamide
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.
Sponsors
China Medical University, China
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache) | The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Blood pressure will be measured before and after the hiking. | 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. |
| Heart rate | Heart rate will be measured before and after the hiking. | 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. |
| Arterial oxygen saturation | Arterial oxygen saturation will be measured before and after the hiking. | 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. |
Countries
Taiwan
Outcome results
None listed