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

NCT01536288 | Completed Phase 2 DMC

• 1 other identifier: NSC 99-3114-B-182A-002
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Mountain Sickness; Environmental Illness

Keywords

acute mountain sickness; AMS; Rhodiola Crenulata; mountaineering; pulse oximetry; oxygen saturation

Outcome Measures

Primary Outcomes (1)

• 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.

  within 18 hours after ascent to altitude 3100m

Secondary Outcomes (3)

• blood oxygen content

  on arrival of altitude 3100m

• severe AMS

  within 18 hours after ascent to altitude 3100m

• severity of headache, incidence of headache and severe headache

  Within 18 hours after ascent to altitude 3100m

Study Arms (2)

Rhodiola crenulata-placebo sequence

ACTIVE COMPARATOR

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; Drug: placebo

Placebo-Rhodiola crenulata sequence

ACTIVE COMPARATOR

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; Drug: placebo

Interventions

Rhodiola crenulata DRUG

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

Also known as: Rhodiola, Golden root, Hong Jing Tian

Placebo-Rhodiola crenulata sequence; Rhodiola crenulata-placebo sequence

placebo DRUG

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

Also known as: Starch

Placebo-Rhodiola crenulata sequence; Rhodiola crenulata-placebo sequence

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Dept of Emergency medicine, Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

Location

Related Publications (29)

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  PMID: 24176010 DERIVED

Related Links

• International society of mountain medicine
• Acute mountain sickness, Kingnet, national web hospital
• American college emergency physicians
• wilderness medicine, medicine and the spirit of adventure

MeSH Terms

Conditions

Altitude Sickness; Environmental Illness

Interventions

Starch

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Hypersensitivity; Immune System Diseases; Disorders of Environmental Origin

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Te-Fa Chiu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2011-11

Locations

TW (1)