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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01536288

Collaborator

National Science Council, Taiwan (Other)

125

Enrollment

Location

Arms

Duration (Months)

17.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Mountain Sickness Environmental Illness	Drug: Rhodiola crenulata Drug: placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Starch

Arm

Intervention/Treatment

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 Names:

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 Names:

Starch

Outcome Measures

Primary Outcome Measures

Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. [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 Outcome Measures

blood oxygen content [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.
severe AMS [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.
severity of headache, incidence of headache and severe headache [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.