Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
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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 |
- 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.
- 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 |
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 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 May 21, 2013