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

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ClinicalTrials.gov Identifier: NCT01682551
Recruitment Status : Unknown
Verified September 2012 by China Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2012
Last Update Posted : September 17, 2012
Sponsor:
Collaborator:
China Medical University, China
Information provided by (Responsible Party):
China Medical University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness (AMS) Drug: Chinese Medicine Drug: Acetalozamide Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
Study Start Date : September 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: "Wu Zhu Yu Tang"
Placebo Comparator: 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".
Drug: 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.
Other Name: "Wu Zhu Yu Tang"
Drug: 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".



Primary Outcome Measures :
  1. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache) [ Time Frame: 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 Outcome Measures :
  1. Blood pressure [ Time Frame: 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.

  2. Heart rate [ Time Frame: 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.

  3. Arterial oxygen saturation [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682551


Locations
Taiwan
School of Chinese Medicine, China Medical University Enrolling by invitation
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
China Medical University, China

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01682551     History of Changes
Other Study ID Numbers: NRICM-10101
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by China Medical University Hospital:
High altitude illness
Chinese medicine body constitution
Chinese Medicine
High altitude medicine
Mountain trekking

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases