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CTRI Number  CTRI/2021/09/036110 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 28/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Yoga Nidra and Preksha Meditation for Mixed Anxiety and Depression Condition 
Scientific Title of Study   A Comparative Clinical Evaluation of Yoga Nidra and Preksha Meditation in the Management of Mixed Anxiety Depressive Disorder 
Trial Acronym  Clinical trial in MADD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof J S Tripathi 
Designation  Professor and Former Head 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikista Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9838706393  
Fax    
Email  drjstripathi@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof J S Yadav 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Psychiatry IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8317025393  
Fax    
Email  jsypsyjai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Kumari 
Designation  Research Scholar  
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7991153209  
Fax    
Email  anajitu@gmail.com  
 
Source of Monetary or Material Support  
UGU FELLOWSHIP AND CONTINGENCY  
 
Primary Sponsor  
Name  UGC FELLOWSHIP AND CONTINGENCY 
Address  NET Bureau, University of Delhi, South Campus, Benito Juarez Marg, New Delhi- 110021 
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 
PRIYANKA KUMARI  SS HOSPITAL BHU  DEPARTMENT OF KAYACHIKITSA FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH 		 7991153209

anajitu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Institute of Medical Sciences, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F413||Other mixed anxiety disorders, (2) ICD-10 Condition: F413||Other mixed anxiety disorders,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical
2Intervention ArmProcedure-Preksha Meditation (Procedure Reference: Preksha Meditation Acharya Mahapragya , 1978, Procedure details: It has eight components which are used in different combinations i.e., Kayotsarg (relaxation), Antaryatra (internal trip), Shwas preksha (perception of breathing), Shareer preksha (perception of body), Chaitanya kendra preksha (perception of psychic centers), Lesya dhyana (perception of psychic colors), Anupreksha (contemplation), and Bhavana (positive feelings).)
(1) Medicine Name: Saraswat Churna, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Duration: 3 Months
3Intervention ArmProcedure-Yoga Nidra (Procedure Reference: SWAMISATYANAND SARSWATI, YOGA PUBLICATION TRUST, MUNGER, BIHAR, INDIA, Procedure details: Eight stages of Yoga Nidra First Stage: Physical Relaxation Second Stage: Resolution Third Stage: Rotation of Consciousness Fourth Stage: Awareness of Breathing Fifth Stage: Feeling of Opposite Emotions Sixth Stage: Visualisation Seventh Stage: Resolution Eighth Stage: Externalization Eight stages of Yoga Nidra First Stage: Physical Relaxation Second Stage: Resolution Third Stage: Rotation of Consciousness Fourth Stage: Awareness of Breathing Fifth Stage: Feeling of Opposit)
(1) Medicine Name: Saraswat Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Duration: 2 Days
(2) Medicine Name: Saraswat Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Newly Diagnosed Patients fulfilling the diagnostic criteria of MADD according to DSM-4.
2. Age range between 20-60 years belonging to either sex.
3. Patients giving the informed consent.
 
 
ExclusionCriteria 
Details  1. Patients who have undergone treatment with MAO inhibitors or any other SSRI antidepressants
2. Patients with prior history of seizures.
3. Psychiatric diseases resembling clinical presentation of MADD like Major Depressive Disorder, Dysthymic Disorder, panic Disorder, or Generalized Anxiety Disorder.
4. Patients having history of chronic illnesses such as Asthma, Tuberculosis and AIDS etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement into the clinical signs and symptoms.
Reduction of the scores of
DASS. Improvement of the scores of WHO Quality of Life. 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Positive and promotive improvement in the mental health   90 days 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 3 
Date of First Enrollment (India)   16/09/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The research work is based on the patients suffering from MADD visiting to Sir Sundarlal Hospital, BHU, Varanasi under the supervision of Prof. J. S. Tripathi & Co- Supervision of 1. Prof. J.S. Yadav Department of Psychiatry IMS, BHU & 2. Prof. S. K. Dwivedi, Department of Sanskrit, Faculty of Arts, BHU. This is an interventional type of study in which two Yogic Interventions viz Yoga Nidra & Preksha Meditation has been selected. Study is being conducted on 150 patients randomly divided into 3 groups. 

Diagnosed cases of MADD are  being registered from O.P.D. of Division of Manas Rog (Neuro – Psychiatry & Psychosomatic Medicine), Deptt. of Kayachikitsa, Sir Sundar Lal Hospital, I.M.S., B.H.U., Varanasi. DASS-42 Scale and WHO Quality of Life Bref Assessment Parameters are being used  for assessment of  anxiety and depression and quality of life of the patients of MADD. 

 
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