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CTRI Number  CTRI/2022/08/044807 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 13/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Pranic Healing]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on different sensations between hands 
Scientific Title of Study   Single blinded, Randomised Controlled Trial on experiences between hands during MCKS sensitization practice 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinu V 
Designation  Research Associate 
Affiliation  World Pranic Healing Foundation, India - Research Centre 
Address  World Pranic Healing Foundation, India 44, 4 main 1 cross Saraswathipuram Mysuru

Mysore
KARNATAKA
570009
India 
Phone  08212340673  
Fax    
Email  research@pranichealing.co.in  
 
Details of Contact Person
Scientific Query  
Name  Vinu V 
Designation  Research Associate 
Affiliation  World Pranic Healing Foundation, India - Research Centre 
Address  World Pranic Healing Foundation, India 44, 4 main 1 cross Saraswathipuram Mysuru

Mysore
KARNATAKA
570009
India 
Phone  09901502828  
Fax    
Email  research@pranichealing.co.in  
 
Details of Contact Person
Public Query  
Name  Vinu V 
Designation  Research Associate 
Affiliation  World Pranic Healing Foundation, India - Research Centre 
Address  World Pranic Healing Foundation, India 44, 4 main 1 cross Saraswathipuram Mysuru

Mysore
KARNATAKA
570009
India 
Phone  08212340673  
Fax    
Email  research@pranichealing.co.in  
 
Source of Monetary or Material Support  
World Pranic Healing Foundation India 
 
Primary Sponsor  
Name  World Pranic Healing Foundation India Research Centre 
Address  Darsons 12 Hospital Road Shivajinagar Bangalore 560001 
Type of Sponsor  Other [Trust ] 
 
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 Sandhya  Govt Nature Cure and Yoga College, Mysuru  Patanjali Yoga Auditorium Govt Nature Cure and Yoga College, Brindavan Extension 1st Stage, KRS Road Mysuru
Mysore
KARNATAKA 		 8904221339

sandhunenapu1289@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics committee – World Pranic Healing Foundation India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - Hand sensitisation practice  MCKS hand sensitisation practice with four varied stages including moving hands slightly back and forth (10 min), touching tongue to the palate (10 min), abdominal breathing (15 min), and practicing barefoot on the ground (20 min). Overall study time will be 4 Hours. 
Comparator Agent  Group B- Placebo   Sham hand gestures (outside facing palms) with four varied stages including moving hands slightly back and forth (10 min), touching tongue to the palate (10 Min), abdominal breathing (15 Min), and barefoot on the ground (20 Min). Overall study duration will be 4 Hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Those who consent to participate in the study
Both male and female students with age ≥ 18 years.
 
 
ExclusionCriteria 
Details  Those with diabetes, hyperesthesia, and Peripheral neuropathy.
Those with sensory impairment
Withdraw consent  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Experiences of sensations between hands using Sensitisation of Hands Feedback Questionnaire
Mood Changes using Brief Mood Introspection Scale
 		 4 hours  
 
Secondary Outcome  
Outcome  TimePoints 
• Correlation of sensation between hands and Peak Flow score (Lung volume)
• Correlation of sensation between hands and Nature connectedness scores (Connectedness to Nature Scale)
Correlation of sensation between hands and BMI
 		 4 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="108" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/08/2022 
Date of Study Completion (India) 30/11/2022 
Date of First Enrollment (Global)  24/08/2022 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [research@pranichealing.co.in].

  6. For how long will this data be available start date provided 20-10-2022 and end date provided 20-06-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This randomized, participant-blinded trial aims to study qualitative and quantitative experiences during hand sensitization practice. The correlation of sensation between hands with BMI, nature connectedness, and peak flow score will be determined. Students will be randomised into two groups. The experimental group will practice the inside-facing palm procedure. The Control group will be guided with a sham practice of outside-facing palm. 
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