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

Acute Mountain Sickness (AMS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01682551
• Other study ID #: NRICM-10101
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 5, 2012
• Last updated: September 13, 2012
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Mountain Sickness (AMS)
• Altitude Sickness

Intervention

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.
• 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".

Locations

Country	Name	City	State
Taiwan	School of Chinese Medicine, China Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	China Medical University, China

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.	No
Secondary	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.	Blood pressure will be measured before and after the hiking.	No
Secondary	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.	Heart rate will be measured before and after the hiking.	No
Secondary	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.	Arterial oxygen saturation will be measured before and after the hiking.	No