Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
NCT ID: NCT01682551
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2012-09-30
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Chinese 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.
Chinese 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.
Acetazolamide
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".
Chinese 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.
Acetalozamide
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".
Interventions
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Chinese 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.
Acetalozamide
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".
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
70 Years
ALL
Yes
Sponsors
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China Medical University, China
OTHER
China Medical University Hospital
OTHER
Responsible Party
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Locations
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School of Chinese Medicine, China Medical University
Taichung, Taiwan, Taiwan
Countries
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Other Identifiers
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NRICM-10101
Identifier Type: -
Identifier Source: org_study_id