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

Primary Purpose

Acute Mountain Sickness (AMS)

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Chinese Medicine
Acetalozamide
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness (AMS) focused on measuring High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Chinese Medicine, China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chinese Medicine

Acetazolamide

Arm 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.

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".

Outcomes

Primary Outcome Measures

The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
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

Blood pressure
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.
Heart rate
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.
Arterial oxygen saturation
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.

Full Information

First Posted
September 5, 2012
Last Updated
September 13, 2012
Sponsor
China Medical University Hospital
Collaborators
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01682551
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
China Medical University, China

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness (AMS)
Keywords
High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Medicine
Arm Type
Experimental
Arm 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.
Arm Title
Acetazolamide
Arm Type
Placebo Comparator
Arm Description
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".
Intervention Type
Drug
Intervention Name(s)
Chinese Medicine
Other Intervention Name(s)
"Wu Zhu Yu Tang"
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Acetalozamide
Intervention Description
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 Measure Information:
Title
The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
Description
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.
Time Frame
The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.
Secondary Outcome Measure Information:
Title
Blood pressure
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 blood pressure will be measured before and after hiking.
Time Frame
Blood pressure will be measured before and after the hiking.
Title
Heart rate
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 heart rate will be measured before and after hiking.
Time Frame
Heart rate will be measured before and after the hiking.
Title
Arterial oxygen saturation
Description
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.
Time Frame
Arterial oxygen saturation will be measured before and after the hiking.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
School of Chinese Medicine, China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

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

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