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

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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

, , 


Verification Date

September 2012