Prophylactic sumatriptan for prevention of Acute Mountain Sickness: a double blind, randomised, placebo controlled, clinical trial
Completed
- Conditions
- Acute mountain sicknessInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN87201238
- Lead Sponsor
- Imam Neurology Research Center (Iran)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
1. Age of 18 to 60 years
2. Ascent to a high altitude of 3500 to 3900 metres above sea level from an altitude of at least 1500 metres
3. Consenting participant
4. May reasonably be expected to complete a 24 hour trial
Exclusion Criteria
1. Other neuro-vascular disease such as cerebrovascular accident, and hypoxic cerebral damage
2. Cardiovascular disease such as ischaemic heart disease, coronary artery disease, significant valvular disease, congestive heart failure, and uncontrolled hypertension with systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg
3. Pregnancy
4. Hypersensitivity to either sumatriptan or acetazolamide or their components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium)
- Secondary Outcome Measures
Name Time Method 1. AMS severity (score more than or equal to five) due to Lake Louise protocol after 24 hours (self-report and clinical assessment)<br>2. Altitude headache occurrence and severity