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

Phase 2

• Conditions: Acute Mountain Sickness (AMS)
• Interventions: Drug: Chinese Medicine; Drug: Acetalozamide

• Registration Number: NCT01682551
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Medicine	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.
Acetazolamide	Chinese Medicine	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".
Acetazolamide	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".

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	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.
Heart rate	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.
Arterial oxygen saturation	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.

Trial Locations

Locations (1)

School of Chinese Medicine, China Medical University; 🇨🇳 Taichung, Taiwan