| CTRI Number |
CTRI/2025/07/091262 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [6h Simulated microgravity] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of simulated microgravity on body function |
|
Scientific Title of Study
|
Impact of Six Hours of Dry Supine Immersion on Body Composition, Heart Rate Variability, Pulmonary Function and Vascular Dynamics in Females |
| Trial Acronym |
DSI 6h |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Bangalore
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Institute of Aerospace Medicine, Indian Air Force
Bangalore
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Institute of Aerospace Medicine, Indian Air Force
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGAFMS AND DRDO Ministry of Defence New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
DGAFMS |
| Address |
Office of the DGAFMS Ministry of Defence Delhi 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Oommen Savina George |
Institute ofAerospaceMedicine |
Simulation Microgravity Laboratory Dept of Space and Environment Physiology
Bangalore
KARNATAKA |
08025224131
savinaoommen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Aerospace Medicine IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
6h exposure to simulated microgravity |
6 hour exposure to simulated microgravity in the form of Dry Supine Immersion |
| Comparator Agent |
Not Applicable |
0 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Healthy volunteers, BMI 20-25 |
|
| ExclusionCriteria |
| Details |
Acute Viral Illneses
Low Backache
Comormidities Hypertension/ Diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in parameters |
6h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Body Composition |
6h |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
(a) To assess body composition in females after six hours of dry supine immersion. (b) To evaluate the autonomic cardiovascular function during simulated microgravity. (c) To evaluate the vascular blood flow dynamics in the above individuals before and after simulated microgravity. (d) To assess lung function before and after microgravity.
To study the body composition, pulmonary function, autonomic cardiovascular response and blood flow dynamics in healthy females during exposure to 06 hours of simulated microgravity using thermoneutral Dry Supine Immersion (DSI) facility. |