Skip to main content
OpenTrials
Completed

NCT Number: NCT01536288

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept of Emergency medicine, Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rhodiola crenulata

Drug

Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering

Other names: Rhodiola, Golden root, Hong Jing Tian

Placebo

Drug

Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering

Other names: Starch

Primary outcomes

  1. 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

    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 outcomes

  1. blood oxygen content

    Time frame: on arrival of altitude 3100m

    Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m.

  2. severe AMS

    Time frame: within 18 hours after ascent to altitude 3100m

    Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.

  3. severity of headache, incidence of headache and severe headache

    Time frame: Within 18 hours after ascent to altitude 3100m

    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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 22, 2012
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.