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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by China Medical University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
China Medical University, China
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01682551
First received: September 5, 2012
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Acute Mountain Sickness (AMS)
Drug: Chinese Medicine
Drug: Acetalozamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood pressure will be measured before and after the hiking. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Heart rate will be measured before and after the hiking. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Arterial oxygen saturation will be measured before and after the hiking. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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".
Other Name: Acetalozamide

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01682551     History of Changes
Other Study ID Numbers: NRICM-10101
Study First Received: September 5, 2012
Last Updated: September 13, 2012
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014