A study to know the effectiveness of Ayurveda Supplements and Yoga Protocol in preventing and reducing the symptoms of Acute Mountain Sickness.

Phase 3

Not yet recruiting

• Conditions: ACUTE MOUNTAIN SICKNESS (ICD 10 : T70.29)

• Registration Number: CTRI/2023/03/051028
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Based on the available empirical and scientific evidence, the proposed clinical study has been planned to evaluate the efficacy of Ayurveda supplements along with yoga protocol in reducing the incidence of acute mountain sickness and thromboembolic events and to combat the stress related to high altitude and cold climatic conditions in Defence personnel deployed at high altitude areas.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-17
• Study Start: 2023-03-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1660

Inclusion Criteria

• 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

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary:	Baseline to first seven days, then on the first four days at each altitude.
•Incidence of AMS assessed through Lake Louise Scoring System (2018)	Baseline to first seven days, then on the first four days at each altitude.
•Proportion of participants with LLSS score ≥ 6.	Baseline to first seven days, then on the first four days at each altitude.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Field hospital Northern Command of Indian Army Nimoo; 🇮🇳 JAMMU, & KASHMIR, India

Field hospital, Northern Command of Indian Army, General Area - Phobrang; 🇮🇳 JAMMU, & KASHMIR, India

Field hospital Northern Command of Indian Army Nimoo

🇮🇳JAMMU, & KASHMIR, India

Col Dr Arun Kumar Yadav

Principal investigator

9868815430

arunyadavpsm@gmail.com