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Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness

Primary Purpose

Acute Mountain Sickness, Environmental Illness

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Rhodiola crenulata
placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness focused on measuring acute mountain sickness, AMS, Rhodiola Crenulata, mountaineering, pulse oximetry, oxygen saturation

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 20 and 55 years.
  • able to complete the study protocol of 9-day study regimens and mountain climbing twice.
  • no prophylactic medication or herb one month before ascent.
  • maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering.

    • living in the same altitude or within a difference of 200 meters.
    • no additional physical training.
    • no plan to gain or loss weight.
    • no altitude exposure above 2500m.

Exclusion Criteria:

  • any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency.
  • women in pregnancy or intending of pregnancy during the 4-month study period.

Sites / Locations

  • Dept of Emergency medicine, Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rhodiola crenulata-placebo sequence

Placebo-Rhodiola crenulata sequence

Arm Description

Rhodiola crenulata for the first treatment period and placebo for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.

Placebo for the first treatment period and Rhodiola crenulata for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.

Outcomes

Primary Outcome Measures

Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
The LLS rates 5 symptoms (headache, gastrointestinal symptoms such as nausea and vomiting, fatigue and/or weakness, dizziness and/or light-headedness, and difficulty sleeping), with each item graded on a scale from 0 to 3. A score of 3 points or greater constitutes AMS.

Secondary Outcome Measures

blood oxygen content
Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m.
severe AMS
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.
severity of headache, incidence of headache and severe headache
severe headache is determined by cut off between scores of 1 and 2 on the Lake Louise survey (ascending scale of 0-3 for severity)

Full Information

First Posted
February 16, 2012
Last Updated
February 21, 2012
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01536288
Brief Title
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness
Official Title
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
Detailed Description
The number of people traveling to altitude for work or for recreation is rising, and increased media attention towards these activities has also raised the profile of altitude related illness. The most effective preventive measure for acute mountain sickness (AMS)-gradual ascent-is frequently difficult or impractical for modern international travel to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to solve this problem, prophylactic acetazolamide was most commonly used. But prescription needed and side effects such as paresthesia and nausea are the disadvantage of using acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness, Environmental Illness
Keywords
acute mountain sickness, AMS, Rhodiola Crenulata, mountaineering, pulse oximetry, oxygen saturation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhodiola crenulata-placebo sequence
Arm Type
Active Comparator
Arm Description
Rhodiola crenulata for the first treatment period and placebo for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
Arm Title
Placebo-Rhodiola crenulata sequence
Arm Type
Active Comparator
Arm Description
Placebo for the first treatment period and Rhodiola crenulata for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
Intervention Type
Drug
Intervention Name(s)
Rhodiola crenulata
Other Intervention Name(s)
Rhodiola, Golden root, Hong Jing Tian
Intervention Description
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Starch
Intervention Description
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Primary Outcome Measure Information:
Title
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
Description
The LLS rates 5 symptoms (headache, gastrointestinal symptoms such as nausea and vomiting, fatigue and/or weakness, dizziness and/or light-headedness, and difficulty sleeping), with each item graded on a scale from 0 to 3. A score of 3 points or greater constitutes AMS.
Time Frame
within 18 hours after ascent to altitude 3100m
Secondary Outcome Measure Information:
Title
blood oxygen content
Description
Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m.
Time Frame
on arrival of altitude 3100m
Title
severe AMS
Description
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.
Time Frame
within 18 hours after ascent to altitude 3100m
Title
severity of headache, incidence of headache and severe headache
Description
severe headache is determined by cut off between scores of 1 and 2 on the Lake Louise survey (ascending scale of 0-3 for severity)
Time Frame
Within 18 hours after ascent to altitude 3100m

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 20 and 55 years. able to complete the study protocol of 9-day study regimens and mountain climbing twice. no prophylactic medication or herb one month before ascent. maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering. living in the same altitude or within a difference of 200 meters. no additional physical training. no plan to gain or loss weight. no altitude exposure above 2500m. Exclusion Criteria: any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency. women in pregnancy or intending of pregnancy during the 4-month study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te-Fa Chiu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Emergency medicine, Chang Gung Memorial Hospital
City
Kweishan
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Links:
URL
http://www.liebertpub.com/products/product.aspx?pid=65
Description
High Altitude Medicine & Biology
URL
http://www.ismmed.org/
Description
International society of mountain medicine
URL
http://hospital.kingnet.com.tw/essay/essay.html?category=%C2%E5%C3%C4%AFe%AFf&pid=13719
Description
Acute mountain sickness, Kingnet, national web hospital
URL
http://www.acep.org/
Description
American college emergency physicians
URL
http://www.wilderness-medicine.com/
Description
wilderness medicine, medicine and the spirit of adventure

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Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness

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