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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhodiola crenulata | Drug | Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| blood oxygen content | Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m. | on arrival of altitude 3100m |
| severe AMS |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Te-Fa Chiu, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Emergency medicine, Chang Gung Memorial Hospital | Kweishan | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11450659 | Background | Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available. | |
| 21844157 | Background | Imray C, Booth A, Wright A, Bradwell A. Acute altitude illnesses. BMJ. 2011 Aug 15;343:d4943. doi: 10.1136/bmj.d4943. No abstract available. |
| Label | URL |
|---|---|
| International society of mountain medicine | View source |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| D018876 | Environmental Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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|
| placebo | Drug | Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering |
|
|
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.
| within 18 hours after ascent to altitude 3100m |
| severity of headache, incidence of headache and severe headache | 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) | Within 18 hours after ascent to altitude 3100m |
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| 24176010 | Derived | Chiu TF, Chen LL, Su DH, Lo HY, Chen CH, Wang SH, Chen WL. Rhodiola crenulata extract for prevention of acute mountain sickness: a randomized, double-blind, placebo-controlled, crossover trial. BMC Complement Altern Med. 2013 Oct 31;13:298. doi: 10.1186/1472-6882-13-298. |
| American college emergency physicians | View source |
| wilderness medicine, medicine and the spirit of adventure | View source |
| D007280 | Disorders of Environmental Origin |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |