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CTRI Number  CTRI/2023/03/051028 [Registered on: 23/03/2023] Trial Registered Prospectively
Last Modified On: 17/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to know the effectiveness of Ayurveda Supplements and Yoga Protocol in preventing and reducing the symptoms of Acute Mountain Sickness. 
Scientific Title of Study   Efficacy of Ayurveda Nutritional Supplements and Yoga Protocol in the Preventing/Reducing of the Severity of Acute Mountain Sickness: An Open-Label RCT. 
Trial Acronym  AYAMS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharti  
Designation  Director 
Affiliation  Central Ayurveda Research Institute 
Address  Central Ayurveda Research Institute, Road No 66, Punjabi Bagh (West), New Delhi
Road No 66, Punjabi Bagh (West), New Delhi
West
DELHI
110026
India 
Phone  9868109737  
Fax    
Email  drbharti2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharti  
Designation  Director 
Affiliation  Central Ayurveda Research Institute 
Address  Central Ayurveda Research Institute, Road No 66, Punjabi Bagh (West), New Delhi
Road No 66, Punjabi Bagh (West), New Delhi

DELHI
110026
India 
Phone  9868109737  
Fax    
Email  drbharti2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharti  
Designation  Director 
Affiliation  Central Ayurveda Research Institute 
Address  Central Ayurveda Research Institute, Road No 66, Punjabi Bagh (West), New Delhi
Road No 66, Punjabi Bagh (West), New Delhi

DELHI
110026
India 
Phone  9868109737  
Fax    
Email  drbharti2@gmail.com  
 
Source of Monetary or Material Support  
Central Council For Research In Ayurvedic Sciences, Janakpuri, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp D Block, Janakpuri, New Delhi - 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Col Dr Arun Kumar Yadav  Field hospital Northern Command of Indian Army Nimoo  C/o 2118 field hospitals, Nimoo/ Leh under the AFMS, Northern Command of Indian Army
Leh (Ladakh)
JAMMU & KASHMIR 		 9868815430

arunyadavpsm@gmail.com 
Col Dr Arun Kumar Yadav  Field hospital, Northern Command of Indian Army, General Area - Phobrang  C/o 2118 field hospitals, General area, Phobrang, under the AFMS, Northern Command of Indian Army
Leh (Ladakh)
JAMMU & KASHMIR 		 9868815430

arunyadavpsm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical committee 153 GH Leh (Ladakh)  Approved 
Institutional Ethical committee 153 GH Leh (Ladakh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ACUTE MOUNTAIN SICKNESS (ICD 10 : T70.29)  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ayush CCT tea, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 125(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Ayush Poshak Yog, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -Ayush CCT Tea), Additional Information: -
3Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yoga Exercise 60 Min daily, Pathya/Apathya:, Pathya:, Apathya:
4Comparator Arm (Non Ayurveda)-Standard CareStandard care as per the existing Indian Army guidelines (physiological, hematological and biochemical parameters)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary:
• Incidence of AMS assessed through Lake Louise Scoring System (2018)
• Proportion of participants with LLSS score ≥ 6. 		 Baseline to first seven days, then on the first four days at each altitude.  
 
Secondary Outcome  
Outcome  TimePoints 
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)  		 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 
 
Target Sample Size   Total Sample Size="1660"
Sample Size from India="1660" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   31/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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