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CTRI Number  CTRI/2024/10/074684 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Interventional Experimental study ]  
Study Design  Other 
Public Title of Study   CVS response and Carotid Arterial Blood Flow Dynamics in females during Simulated Microgravity  
Scientific Title of Study   To Study The Cardiovascular Response and Carotid Arterial Blood Flow Dynamics in Healthy Females During Exposure to 06 Hours of Simulated Microgravity 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KRISHNAVENI M 
Designation  Resident Aerospace Medicine 
Affiliation  Institute of Aerospace Medicine, Indian Airforce 
Address  Department of Environmental and Space Physiology,Institute of Aerospace Medicine HAL Old Airport Road, Vimanapura,Bangalore 560017

Bangalore
KARNATAKA
560017
India 
Phone  09731931665  
Fax    
Email  krishnaveni141094@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Punyashlok Biswal 
Designation  Head of Department Space Medicine 
Affiliation  Institute of Aerospace Medicine 
Address  Department of Space Medicine, Institute of Aerospace Medicine HAL Old Airport Road, Vimanapura,Bangalore 560017

Bangalore
KARNATAKA
560017
India 
Phone  9431523824  
Fax    
Email  drpunyashlok@gmail.com  
 
Details of Contact Person
Public Query  
Name  KRISHNAVENI M 
Designation  Resident Aerospace Medicine 
Affiliation  Institute of Aerospace Medicine 
Address  Departemnt of Environmental and Space Physiology, Institute of Aerospace Medicine HAL Old Airport Road, Vimanapura,Bangalore 560017

Bangalore
KARNATAKA
560017
India 
Phone  09731931665  
Fax    
Email  krishnaveni141094@gmail.com  
 
Source of Monetary or Material Support  
Departemnt of Environmental and Space Physiology, Institute of Aerospace Medicine HAL Old Airport Road, Vimanapura,Bangalore 560017 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnaveni M  Institute of Aerospace Medicine  DSI LAB, Departemnt of Environmental and Space Physiology, Institute of Aerospace Medicine. Old HAL airport road, vimanapura, 560017
Bangalore
KARNATAKA 		 09731931665

krishnaveni141094@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Aerospace Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Simulated Microgravity  Dry supine Immersion for 6 hrs 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) 20 Healthy female volunteers
2) Age: 20-40 years
 
 
ExclusionCriteria 
Details  Medical or treatment history likely to interfere with the study, any acute illness, any known comorbidities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
carotid blood flow dynamics  6 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
heart Rate, Blood Pressure  6 hrs 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/10/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Aim of the Study

To study the cardiovascular response and carotid arterial blood flow dynamics in healthy females during exposure to six hours of simulated microgravity.

Objectives of the Study

To evaluate the temporal variation in autonomic cardiovascular variability including heart rate variability and blood pressure in females at zero, three, and six hours of exposure to simulated microgravity.

To evaluate the carotid arterial blood flow dynamics in females at zero, three, and six hours of exposure to simulated microgravity.

Inclusion Criteria

Twenty healthy female volunteers
Age twenty to forty years

Exclusion Criteria

Medical or treatment history likely to interfere with the study
Any acute illness
Any known comorbidities

 
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