Brief Title
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
Official Title
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
Secondary Outcome
Blood pressure
Condition
Acute Mountain Sickness (AMS)
Intervention
Chinese Medicine
Study Arms / Comparison Groups
Chinese Medicine
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
240
Start Date
September 2012
Completion Date
September 2012
Primary Completion Date
September 2012
Eligibility Criteria
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.
Gender
All
Ages
20 Years - 70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT01682551
Organization ID
NRICM-10101
Responsible Party
Sponsor
Study Sponsor
China Medical University Hospital
Collaborators
China Medical University, China
Study Sponsor
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Verification Date
September 2012