Healthy Volunteers Needed

San Francisco CA

Description

The UCSF Department of Anesthesia is now recruiting healthy volunteers for a clinical trial examining the safety and effectiveness of a new oral treatment for Acute Mountain Sickness. Acute Mountain Sickness may occur when persons ascend rapidly to high altitudes. Symptoms include headache, loss of appetite, fatigue, nausea/vomiting, and poor sleep. A new medication is being tested to see if it is effective in treating these symptoms. Potential volunteers must: - Be healthy volunteers: ages 18 - 55 years old; - Have a primary residence elevation of 1,000 ft or lower; - Not ascend to altitude above10,000 ft within 4 months prior; - Willing to participate voluntarily and to read and sign a written informed consent in English. - Must agree to abstinence or birth control while in the study. Subjects cannot: - Have any personal medical history of cardiovascular, cerebrovascular diseases or respiratory disease; digestive disease, mental disease, metabolic disease, acute infection or anemia; - Cannot be currently experiencing symptoms of AMS; - Have a medical history of primary headache (including migraines); - Have donated blood or had surgery within 3 months prior; - Cannot take any other medications (including any dietary supplements) within 14 days prior and throughout the study period; - Allergy to study treatment of Danshen (Radix Saliva Miltiorrhize Bge., RSM) products; - Cannot be pregnant or in lactation period; - Must be able to pass a drug screening and cannot have a recent history of alcoholism or substance abuse; - Cannot be participating in any other clinical trial or on an investigational drug within 30 days prior. - Cannot be a family member or relative of the study site staff. The study will include a screening visit to determine eligibility, baselines sea-level assessments in San Francisco, CA, and 4 days at high altitude at the White Mountain Research Station in Bishop, CA. The entire study will last 8 days, with 4 sea-level visits and 4 days at altitude. Each sea level visit will take about 1 to 1.5 hours. Study procedures will include a brief physical exam, daily medication dosing, subject questionnaires and diary keeping, routine laboratory tests, and exercise on a stationary bicycle. Subjects will be compensated for their time and travel; time at altitude will include dormitory-style accommodations and all meals. The study team will provide the study medication and travel to the study site at altitude. The study doctors will monitor all subjects for safety during all phases of the study. To learn more, contact the study coordinator at the email address listed. The study is being run by the UCSF Department of Anesthesia with sponsorship from Tasly Pharmaceuticals. Altitude trip dates: August 11th-14th August 22nd-25th August 25th-28th September-5th-8th September 8th-11th September 19th-22nd September 22nd-25th October 3rd-6th October 6th-9th October 17th-20th October 20th-23rd