| CTRI Number |
CTRI/2022/09/045922 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of different modalities for high altitude rapid acclimatization |
|
Scientific Title of Study
|
Strategies for rapid acclimatization to high altitude – using different modalities |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaushik Halder |
| Designation |
Scientist E |
| Affiliation |
DIPAS, DRDO |
| Address |
Department of Soldier Performance, DIPAS, DRDO, Lucknow Road, Timarpur, Delhi
North
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
halderkaushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaushik Halder |
| Designation |
Scientist E |
| Affiliation |
DIPAS, DRDO |
| Address |
Department of Soldier Performance, DIPAS, DRDO, Lucknow Road, Timarpur, Delhi
North
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
halderkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmendra Kumar |
| Designation |
Lt. Col |
| Affiliation |
Armed Forces Medical Services |
| Address |
Dept. of Physiology, HAMRC, C/O 153 General Hospital, Leh
Leh (Ladakh)
JAMMU & KASHMIR
194101
India |
| Phone |
|
| Fax |
|
| Email |
oichamrcleh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Defence Institute of Physiology and Allied Sciences (DIPAS), DRDO, Lucknow Road Timarpur, Delhi-110054
|
|
|
Primary Sponsor
|
| Name |
DEFENCE RESEARCH AND DEVELOPMENTAL ORGANIZATION |
| Address |
Defence Institute of Physiology and Allied Sciences (DIPAS), DRDO,
Lucknow Road, Timarpur, Delhi-110054 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dharmendra Kumar |
Physiology Laboratory |
High Altitude Medical Research Centre, C/O 153 General Hospital, C/O 56 APO
Leh (Ladakh)
JAMMU & KASHMIR |
9765534896
23092931
oichamrcleh@gmail.com |
| Dr Dharmendra Kumar |
Transit Camp, Chandigarh |
Field Lab, Transit Camp
Chandigarh
CHANDIGARH |
9765534896
23092931
oichamrcleh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 153 GH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male lowlanders who had not visited high altitude in last 3 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acetazolamide |
Cap Acetazolamide 250 mg SR
was given orally once daily to
participants of acetazolamide
group day before boarding flight at Chandigarh (D(-1)) to Stage-I HA till day 3.
|
| Intervention |
Intermittent Hypoxic Exposure
(IHE) |
IHE was given at the rate of 12% of FIO2 for four hours per day for four consecutive days inside IHE Chamber established at Chandigarh. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
a) Age group: 20 – 40 years
b) Medical history: SHAPE – I.
|
|
| ExclusionCriteria |
| Details |
a) Smokers
b) Drinker
c) Prior induction to HA
d) Medical history of any sort.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Acute Mountain Sickness |
During the initial days after ascent to high altitude area. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exercise Capacity at High Altitude |
After 48 and 72 hours after reaching high altitude area.
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Exposure at high altitude (HA) induced hypobaric hypoxia is known to deteriorate health and decrease performance. The aim of the study is to develop of Rapid Acclimatization Schedule for High
Altitude in Western sector using different modalities. 400 volunteers within the age range of 20-40 years will be recruited. The volunteers will be randomized into 4 different groups - Control, Drug treated (Acetazolamide), Stay at Moderate Altitude (Short duration) and Intermittent Hypoxia Exposure (IHE). After recording their baseline parameters at Sea Level area they will be inducted to Stage - I HA by air followed by Stage - II HA by road. In all stages different
physiological, physical and biochemical parameters would be assessed. |