Efficacy of Ayurveda Nutritional Supplements and Yoga Protocol in the Preventing/Reducing of the Severity of Acute Mountain Sickness: An Open-Label RCT. - AYAMS

Central Council for Research in Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•1. Apparently healthy Indian Army volunteers aged 18-50 years irrespective of gender
•2. Indian Army volunteers who will be found fit for deployment to high altitude areas (under the Ladakh region of the Northern Command of Indian Army)as per the existing guidelines
•3. Indian Army volunteers who will be either deployed to high altitude area for the first time or resumed their deployment after break
•4. Willing to participate and provide written informed consent.

•1. History of underlying cardiovascular disease or a clinically significant ECG abnormality, cerebrovascular disease, pulmonary disease, neurological disease, psychiatric illness, major venous thromboembolism (deep vein thrombosis/pulmonary embolism/cerebrovascular thrombosis), sickle-cell disease, metabolic diseases, malignancy, glaucoma etc.
•2. Previous history of pulmonary edema or severe physiological response to high altitude such as high altitude pulmonary edema
•3. History of uncontrolled DM (HbA1C > 8.0) and uncontrolled hypertension ( > 140/90 mm Hg) even after medications
•4. BMI >= 30 kg/m2
•5. History of abnormal hepatic function (AST and/or ALT, > 2 times upper normal limit) or abnormal renal function (serum creatinine 1.2 mg%)
•6. Subjects on any concomitant conventional medication on regular basis
•7. History of surgery within six months prior to screening
•8. History of blood transfusion or any blood products within 90 days prior to screening
•9. History of chain smoking, alcohol use disorder and substance abuse
•10. Any other condition which the P.I. thinks may jeopardize the safety of the subjects

发起方