None listed
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: â?¢Incidence of AMS assessed through Lake Louise Scoring System (2018) â?¢Proportion of participants with LLSS score â?¥ 6.Timepoint: Baseline to first seven days, then on the first four days at each altitude. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with thromboembolic events (DVT, PE, CVT, MI etc.) (DVT will be assessed through hand held vascular Doppler and other thromboembolic disorders will be assessed clinically and through relevant investigations) 2. Proportion of participants with normal markers of coagulation and hemostasis activation 3. Change in the markers of coagulation and hemostasis (Total RBC, Hb%, PCV, D-dimer, LDH, CK, CK-MB, fibrinogen, activated partial thromboplastin time, prothrombin time) 4. Change in pro-inflammatory markers (hs-CRP, IL-6, TNF-α) 5. Change in the safety laboratory parameters (CBC, LFT, KFT, Lipid profile) 6. Change in stress levels, mood states and sleep quality (assessed through DASS21 and PSQI) 7. Change in the quality of life parameters (assessed through SF-12 Questionnaire)Timepoint: 1. Day 60, 120 2. Day 60, 120 3. Baseline, Day 60, 4. Baseline, Day 60, 120 5. Baseline, Day 60, 120 6. Baseline, Day 60, 120 7. Baseline, Day 60, 120 | — |
Countries
India
Contacts
Public ContactDr Bharti
Central Ayurveda Research Institute
Outcome results
None listed