NCT01682551

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

Same day

First QC Date

September 5, 2012

Last Update Submit

September 13, 2012

Conditions

Acute Mountain Sickness (AMS)

Keywords

High altitude illnessChinese medicine body constitutionChinese MedicineHigh altitude medicineMountain trekking

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Blood pressure

    Blood pressure will be measured before and after the hiking.

  • Heart rate

    Heart rate will be measured before and after the hiking.

  • Arterial oxygen saturation

    Arterial oxygen saturation will be measured before and after the hiking.

Study Arms (2)

Chinese Medicine

EXPERIMENTAL

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

Acetazolamide

PLACEBO COMPARATOR

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 MedicineDrug: Acetalozamide

Interventions

Chinese MedicineDRUG

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.

Also known as: "Wu Zhu Yu Tang"
AcetazolamideChinese Medicine
AcetalozamideDRUG

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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine, China Medical University

Taichung, Taiwan, 404, Taiwan

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 11, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

TW(1)