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CTRI Number  CTRI/2023/10/059039 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 22/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bandha hasta utthanasana for improvenment in blood supply to brain for healthy individuals  
Scientific Title of Study   Immediate effects of bandha hasta utthanasana on cerebral hemodynamics in healthy individuals: a randomized controlled trail  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Abirami 
Designation  PG Scholar 
Affiliation  Government Yoga and Naturopathy Medical College and Hospital. 
Address  Government Yoga and Naturopathy Medical College and Hospital, PG Block, Department of Yoga, Second floor, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9841659102  
Fax    
Email  abiramimanickam4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  S T Venkateswaran 
Designation  Professor, Head of the deparment (Yoga) 
Affiliation  Government Yoga and Naturopathy Medical College and Hospital. 
Address  Government Yoga and Naturopathy Medical College and Hospital, PG Block, Department of Yoga, Second floor, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9444227007  
Fax    
Email  stvspeech@gmail.com  
 
Details of Contact Person
Public Query  
Name  M Abirami 
Designation  PG Scholar 
Affiliation  Government Yoga and Naturopathy Medical College and Hospital. 
Address  Government Yoga and Naturopathy Medical College and Hospital, PG Block, Department of Yoga, Second floor, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9841659102  
Fax    
Email  abiramimanickam4@gmail.com  
 
Source of Monetary or Material Support  
Government Yoga and Naturopathy Medical College and Hospital, PG Block, Second floor, Research Department, Arumbakkam, Chennai 600 106 
 
Primary Sponsor  
Name  The Tamil Nadu Dr. M.G.R. Medical University 
Address  The Tamil Nadu Dr. M.G.R. Medical University No. 69, Anna Salai, Guindy, Chennai - 600 032, Tamilnadu India. 
Type of Sponsor  Government funding agency 
 
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 M Abirami  Government Yoga and Naturopathy Medical College and Hospital.  Government Yoga and Naturopathy Medical College and Hospital, PG Block, Second floor, Research Department, Arumbakkam, Chennai 106.
Chennai
TAMIL NADU 		 9841659102

abiramimanickam4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Yoga and Naturopathy Medical College and Hospital, Chennai Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers age group between 18 to 49 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bandha hasta utthanasana  The subject will be asked to practice Bandha Hasta Utthanasana as follows: Subjects will be asked to sit in stand erect with feet together and the arms by the sides. And asked to Relax the whole body and balance the body weight equally on both feet. After that ask to cross the wrists in front of the body. Inhale slowly raising the arms above the head, keeping the wrist crossed at the same time bend the head slightly backward and look up at the hands and exhale while spreading them out to the sides, form a straight line at shoulder level, hold the position, inhale while re-crossing the wrist above the head, and exhale while lower the arms in the starting position. Repeat the process 5 times for 10 minutes 
Comparator Agent  Subjects will not receive any intervention.  Subjects will not receive any intervention. The subjects will be asked to sit in any comfortable posture for 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  subjects who are willing to give their consent, both male and female, age group between 18 -49 years 
 
ExclusionCriteria 
Details  Participants with systemic disorder, thrombosis, psychosomatic illness, and recent surgical history will be excluded from this study. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assesment of cerebral hemodynamics (oxyhemoglobulin, deoxyhemoglobulin, and total hemoglobulin)   Effect of bandha hasta utthanasana baseline will be assessed before the practice , immediately after the 5minutes of practice post variable will be assessed on the same day. Assesment of cerebral hemodynamics (oxyhemoglobulin, deoxyhemoglobulin, and total hemoglobulin) will done before and immediately after the intervention by using FNIRS (Functional near infrared spetroscopy) device,LLC model,protomac, model:2000s-v1.2 biopac system. 
 
Secondary Outcome  
Outcome  TimePoints 
Blood pressure will be measured before and immediately after the intervention as well as in control with digital blood pressure.  (5minutes)Blood pressure will be measured before and immediately after the intervention as well as in control. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/10/2023 
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="1"
Days="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  abiramimanickam4@gmail.com

  6. For how long will this data be available start date provided 04-09-2025 and end date provided 01-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Yoga is a subtle and right living science that contain yama, nyama, asana, pranayama, prathyaha, dharana, dhyana, and samadhi. In asana bantha hasta utthanasana is a standing asana it may be practiced in both high-frequency yogic breathing and slow breathing and may produce hypocapnia. In the frontal brain, the prefrontal cortex which is responsible for the performance of cognitive tasks requires delivery of adequate oxygen. FNIRS Functional near-infrared spectroscopy can be used as a tool to measure variation in the blood flow of oxy and deoxyhemoglobin, brought on by cerebral activation. It is a randomized controlled trial convenient sampling technique will be used for this study. 60 subjects will be recruited for this study. 30 subjects will be in the intervention group and 30 subjects will be in the control group. The intervention group will practice bandha hasta utthanasana for 5 minutes . whereas control group asked sit quietly for 5 minutes. Primary outcome variable assessment of cerebral hemodynamics by using FNRIS device, will be done before and immediately after the intervention and control group. Seconadry outcome variable will be blood pressure. it will be measured before and after the intervention as well as in control group. 
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