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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Environmental Illness; Acute Mountain Sickness

Treatments: Drug: placebo; Drug: Rhodiola crenulata

Study type: Interventional

Funder types: Other

Identifiers

NCT01536288

NSC 99-3114-B-182A-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

Rhodiola crenulata-placebo sequence

Active Comparator group

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.

Treatment:

Drug: Rhodiola crenulata

Drug: placebo

Placebo-Rhodiola crenulata sequence

Active Comparator group

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.

Treatment:

Drug: Rhodiola crenulata

Drug: placebo