| CTRI Number |
CTRI/2025/03/083607 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to evaluate the efficacy of BiPAP/CPAP for the prevention of acute mountain sickness |
|
Scientific Title of Study
|
A Pilot study to evaluate the efficacy of prophylactic BiPAP/CPAP ventilation for the prevention of acute mountain sickness in non-acclimatized individuals |
| Trial Acronym |
PEPA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anshul Jain |
| Designation |
Professor |
| Affiliation |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
Department of Anesthesia
Maharani Laxmi Bai Medical College Jhansi
First Floor room no 1
Jhansi
UTTAR PRADESH
285001
India |
| Phone |
9411685406 |
| Fax |
|
| Email |
dranshulrachna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshul Jain |
| Designation |
Professor |
| Affiliation |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
Department of Anesthesiology
MLB Medical College Jhansi
Room number 1
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9411685406 |
| Fax |
|
| Email |
dranshulrachna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesiology
Government Medical College Jalaun
First Floor, Room number 2
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
anilkgmu10@gmail.com |
|
|
Source of Monetary or Material Support
|
| MLB Medical College, Jhansi, UTTAR PRADESH, INDIA, 284128 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Maharani Laxmi Bai Medical College Jhansi Uttar Pradesh- 284128 INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anshul Jain |
M.L.B. Medical College Jhansi and Associated Hospitals |
Department of Anesthesia, Room Numer-1, MLB Medical College Jhansi
Jhansi
UTTAR PRADESH |
9411685406
dranshulrachna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharani Laxmi Bai Medical college Institute Ethical Committee ( Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal health condition |
| Patients |
(1) ICD-10 Condition: T702||Other and unspecified effects of high altitude, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oxygen gas @5lit/min |
oxygen given by hudson mask,@5liter/min on having symptoms of the acute mountain sickness for 3 hours |
| Intervention |
tab Dimox 5mg OD |
tab Dimox 5mg OD for 3 days Orally given to
individuals as preventive major |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
adult male and female of age not more than 60 years, who visited high altitude zone |
|
| ExclusionCriteria |
| Details |
any coronary artery disease
any respiratory disease
hypertensive
diabetic
tubercular treatment
bleeding disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| this is pilot trial to evaluate the efficacy of non invasive ventilation for the prevention of the acute mountain sickness in those people who are not acclimatized |
6, 12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of the dimox tablet |
6,12 and 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Altitude sickness results from a rapid change in air pressure and air oxygen levels at higher elevations. You may have symptoms if you travel to a high elevation without giving your body time to adjust to less oxygen. Acetazolamide is one of the medications for the prevention and treatment of altitude sickness. It increases the breathing rate allowing more oxygen to be taken in. This helps the body adjust to higher altitudes faster and reduces some of the symptoms of altitude sickness. patient who did not get relieved by preventive dose of the tablet dimox, has been given the oxygen supplimentation |