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

September 13, 2012 updated by: China Medical University Hospital
This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • School of Chinese Medicine, China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • "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 Names:
  • "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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Blood pressure will be measured before and after the hiking.
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.
Heart rate will be measured before and after the hiking.
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.
Arterial oxygen saturation will be measured before and after the hiking.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRICM-10101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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