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CTRI Number  CTRI/2021/02/030980 [Registered on: 03/02/2021] Trial Registered Prospectively
Last Modified On: 17/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Yoga intervention in jail inmates and its efficacy in animal model of memory loss 
Scientific Title of Study   Molecular, Cell survival and Neuro-cognitive effects of Yoga intervention in stress induced Cognitive Impairment in Prisoners and its efficacy in animal model of memory loss 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshay Anand 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education & Research (PGIMER)  
Address  Neuroscience Research Lab Department of Neurology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209090  
Fax    
Email  akshay1anand@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akshay Anand 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education & Research (PGIMER)  
Address  Neuroscience Research Lab Department of Neurology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209090  
Fax    
Email  akshay1anand@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Akshay Anand 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education & Research (PGIMER)  
Address  Neuroscience Research Lab Department of Neurology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209090  
Fax    
Email  akshay1anand@rediffmail.com  
 
Source of Monetary or Material Support  
Science and Technology of Yoga and Meditation (SATYAM) 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education Research 
Address  Madhya Marg, Sector 12, Chandigarh,160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akshay Anand  Central Jail, Ambala  Baldev Nagar Thana, Police Line, Ambala Cantt, Haryana 133001
Ambala
HARYANA 		 9914209090

akshay1anand@rediffmail.com 
Akshay Anand   Chandigarh Prison  Chandigarh Sector 51 Chandigarh - 160047
Chandigarh
CHANDIGARH 		 9914209090

akshay1anand@rediffmail.com 
Akshay Anand  District Jail, Kurukshetra  SH 6, Police line, Pipli, Kurukshetra, Haryana 136131
Kurukshetra
HARYANA 		 9914209090

akshay1anand@rediffmail.com 
Akshay Anand  District Jails, Karnal  Mustfabad, Karnal, Haryana 132036
Karnal
HARYANA 		 9914209090

akshay1anand@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Animal Ethics Committee of PGIMER  Approved 
Institutional Ethics Committee of PGIMER  Approved 
NOC of Chandigarh Jail  Approved 
NOC of Haryana Jails  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with mild to moderate cognitive impairment will included in this study. These participant are otherwise healthy. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Common Yoga Protocol developed by the Ministry of AYUSH.  Following intervention will be given for 45 minutes/day, 5 days/week for 2 months. 1. Prayer 2. Loosening Practices A. Neck Bending B.Shoulders movement C.Trunk Movement D.Knee Movement 3. Yogasanas A. Standing Postures i. Tadasana ii. Vakrasana iii. Padahastasana iv. Ardha Cakrasana v. Trikonasana B. Sitting Postures i. Bhadrasana ii. Vajrasana/virasana iii. Ardha Ustrasana (for beginners) iv. Ustrasana v. Sasankasana vi. Uttana Mandukasana vii. Marichyasana/ Vakrasana C. Prone Postures i. Makarasana ii. Bhujangasana iii. Salabhasana D. Supine Postures i. Setubandhasana ii. Uttanapadasana iii. Ardhahalasana iv. Pavanamuktasana v. Savasana 4. Kapalabhati 5. Pranayama A. Nadisodhana / Anuloma Viloma Pranayama B. Sitali Pranayama C. Bhramari Pranayama 6. Dhyana 7. Sankalpa 8. Santih Patha 
Comparator Agent  No intervention  No intervention will be given to control group 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  No previous experience in Yoga.
Giving consent to participate. 
 
ExclusionCriteria 
Details  Those not giving consent to participate.
Noncooperative and aggressive behavior.
Severe cognitive impairment.
Previous experience in Yoga. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
BDNF, VEGF, IL-6,TNF-α, CRP, Cortisol, Dnmt-1,CD34, CD45, CD117, FBS, Mini-Mental State Examination Test (MMSE), Perceived Stress Scale (PSS), State trait anxiety inventory (STAI), WHOQOL-BREF, Hamilton Depression Rating Scale (HAM-D/HDRS), Trail making test (A and B), Stroop color and word test, Wechsler Memory Scale, PPBS, FBS.  At baseline and after two months 
 
Secondary Outcome  
Outcome  TimePoints 
Animal study:
Morris Water Maze, Passive avoidance, Histology and IHC: caspase3, Aβ
Cryosectioning, Congo red staining, Fluoro jade staining, Real time PCR: BDNF, VEGF 		 30 to 60 days 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   05/02/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   This project will leads to good publication in indexed journals. 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [akshay1anand@rediffmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
    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   Cognition is one of the most important process of human brain physiology. There are many factors that govern cognition which makes it vulnerable to imperfections. Any insult like brain damage, stress, depression, anxiety, fear, physical and chemical factors affect hippocampal health and result in diminished memory and cognition. Jail inmates may be the best population to study the association of these risk factors with cognition compared to other. It has been seen that prisoners are under constant stress, depression, anxiety and tension during the life of imprisonment. These factors are the major cause of mental health problems if remains untreated over long period of time. Little is still known about the consequences of prisoner life and their general health conditions in India. Over a long period of isolation in prisons, their mental health status may change leading to feeling of frustration, stress, anger and anxiety. Some coping strategies that address the physical, emotional, cognitive, social, and spiritual domains are promising intervention techniques that can help in improving well-being among the prisoner population. Currently the first line treatments for cognitive disorder includes pharmaceutical agents and psychological interventions, haven’t shown much relief and hope with repeated failure of clinical trials. Lifestyle modifications may have an impact on preventing the progression of such cognitive loss subsequently leading to AD. In this proposal, we propose to administer a customized Yoga protocol to alleviate stress induced cognitive impairment amongst the prisoners and its possible role in either reducing a significant risk factor for cognitive decline and dementia or improving the quality of life. Therefore, it would be scientifically compelling to examine the behavioral parameters to analyze the impact of threatful and fearsome condition on social and associated epigenetic and molecular alteration as well as yoga intervention. Our study plan is based on the focus that prisoners are continuously associated with stress, anxiety and depression which is a known cause of cognitive impairment and whether it is alleviated by a customized Yoga protocol. Furthermore, the efficacy of this protocol will be established by using the lineage negative cells by yoga practicing individuals into animal model of memory loss. 
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