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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01536288
First received: February 16, 2012
Last updated: February 21, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Acute Mountain Sickness
Environmental Illness
Drug: Rhodiola crenulata
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. [ Time Frame: within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: on arrival of altitude 3100m ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 125
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rhodiola crenulata-placebo sequence
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.
Drug: Rhodiola crenulata
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Names:
  • Rhodiola
  • Golden root
  • Hong Jing Tian
Drug: placebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Name: Starch
Active Comparator: Placebo-Rhodiola crenulata sequence
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.
Drug: Rhodiola crenulata
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Names:
  • Rhodiola
  • Golden root
  • Hong Jing Tian
Drug: placebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Name: Starch

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536288

Locations
Taiwan
Dept of Emergency medicine, Chang Gung Memorial Hospital
Kweishan, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Te-Fa Chiu, MD Chang Gung Memorial Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01536288     History of Changes
Other Study ID Numbers: NSC 99-3114-B-182A-002
Study First Received: February 16, 2012
Last Updated: February 21, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Chang Gung Memorial Hospital:
acute mountain sickness
AMS
Rhodiola Crenulata
mountaineering
pulse oximetry
oxygen saturation

Additional relevant MeSH terms:
Altitude Sickness
Environmental Illness
Respiration Disorders
Respiratory Tract Diseases
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014