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

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01682551
• Collaborator: China Medical University, China (Other)
• Enrollment: 240
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Mountain Sickness (AMS)	Drug: Chinese Medicine; Drug: Acetalozamide	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Sep 1, 2012
• Anticipated Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: "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 Names: "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".

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	School of Chinese Medicine, China Medical University	Taichung		Taiwan	404

Sponsors and Collaborators

• China Medical University Hospital
• China Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT01682551
• Other Study ID Numbers: NRICM-10101
• First Posted: Sep 11, 2012
• Last Update Posted: Sep 17, 2012
• Last Verified: Sep 1, 2012

• 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

Study Results

No Results Posted as of Sep 17, 2012