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CTRI Number  CTRI/2022/02/040099 [Registered on: 08/02/2022] Trial Registered Prospectively
Last Modified On: 09/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga Therapy for dementia in elderly with vascular cause 
Scientific Title of Study   To evaluate the effects of Yoga on Cognitive function, activities of daily living, self-reported Depression, and Heart Rate Variability in subjects with Vascular Dementia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raghavendra Rao M 
Designation  Director 
Affiliation  Central Council for Research in Yoga & Naturopathy  
Address  Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  9916488864  
Fax    
Email  raghav.hcgrf@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vadiraj HS 
Designation  Research Officer 
Affiliation  Central Council for Research in Yoga & Naturopathy  
Address  Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  9350147313  
Fax    
Email  vadiraj77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Garima 
Designation  Senior Research Fellow 
Affiliation  CCRYN OPD, Dr. Ram Manohar Lohia Hospital, New Delhi 
Address  Room no. 35,36 Yoga & Naturopathy OPD, Department of Psychiatry, Dr. Ram Manohar Lohia Hospital, New Delhi (Running under the aegis of CCRYN)

New Delhi
DELHI
110001
India 
Phone  9945558931  
Fax    
Email  garimamishrayoga@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Yoga and Naturopathy Ministry of AYUSH 
Address  61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi  
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 Mina Chandra  Room no. 4, Psychiatry OPD  Centre of excellence in Mental Health, Department of Psychiatry, Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Rd. Type III,New Delhi
New Delhi
DELHI 
9811831902

doctorminachandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS & Dr. RML Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F015||Vascular dementia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Yoga Therapy  Patients will be made to perform selected yogic practices including breathing exercises, meditation, and yoga postures for 60 minutes, thrice a week for 2 months (8 weeks) guided by a certified yoga instructor. The medium will primarily be online, and wherever required and possible, assisted with offline sessions. 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Diagnosed case of Vascular Dementia as per DSM V.
2.Age above 55 – 75 years
3.Zubrods performance status 1-2 
 
ExclusionCriteria 
Details  1.Dementia due to any other etiology
2.History of recent /past Head Injury resulting in neurologic deficits
3.History of Neurosurgery-Craniotomy
4.History of Substance Dependence other than Nicotine
5.Those with prior h/o depression, a major psychiatric illness associated with cognitive illness
6.Those with brain metastases
7.Concurrent medical condition likely to influence survival
8.Uncontrolled diabetes, hypertension, and autoimmune disease
9.Neurological disorders such as any significant head injury, epilepsy, Parkinson’s disease, neurodegenerative disorders, etc.
10.Regular participation in an active behavioral intervention/yoga in the last six months
11.H/o recent brain infections or fever in the past two months (meningitis/encephalitis)
12.Those with anemia (Hemoglobin < 10gm %)
13.LVEF<40%
14.H/o recent atrial fibrillation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cognitive Functions  Before and after 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Self-reported Depression   Before and after 2 months 
Heart Rate Variability   Before and after 2 months 
Activities of Daily living  Before and after 2 months 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   14/02/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Yoga-based interventions appear to significantly improve several cognitive domains in elderly such as immediate and delayed recall, verbal and visual memory, attention, working memory, verbal fluency, executive function, and processing speed. Yoga has emerged as an effective and feasible add on therapy in schizophrenia, with special benefits in improving social cognition and negative symptoms. Yoga was found to benefit individuals with depressive symptoms, including quality of life and cognition. Some of the consistent effects of yoga practice include stress reduction, emotion regulation, improved mood and well being. Though, the studies have shown the beneficial effect of Yoga in improving the cognitive functions, no study till date has been studied to understand the role of Yoga in Vascular Dementia. The study will evaluate the effect of yoga on cognitive functions, self reported Dementia, the activity of daily living, and heart rate variability in Vascular dementia patients who are undergoing conventional therapy. This study is a randomized controlled trial, where we will compare two groups, case group - yoga intervention integrated with conventional treatment and control group. There will be 52 participants in each group diagnosed with vascular dementia by the specialist. Assessments of variables will be done at baseline and completion of 8 weeks. The intervention will be given for 8 weeks to all the participants in the case group. 

 
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