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

September 5, 2012
September 13, 2012
September 2012
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01682551 on ClinicalTrials.gov Archive Site
  • 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.

Blood pressure, heart rate and arterial oxygen saturation [ Time Frame: Blood pressure, heart rate and arterial oxygen saturation 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, heart rate and arterial oxygen saturation will measure before and after hiking.
Not Provided
Not Provided
 
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Mountain Sickness (AMS)
  • 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
  • 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.
    Intervention: Drug: Chinese Medicine
  • 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".
    Interventions:
    • Drug: Chinese Medicine
    • Drug: Acetalozamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
Yes
Taiwan
 
NCT01682551
NRICM-10101
Not Provided
China Medical University Hospital
China Medical University Hospital
China Medical University, China
Not Provided
China Medical University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP