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CTRI Number  CTRI/2018/02/011936 [Registered on: 16/02/2018] Trial Registered Prospectively
Last Modified On: 02/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga and its effects on Medically Unexplained Physical Symptoms(pain) 
Scientific Title of Study   Efficacy of Yoga on Symptom Severity and Quality of Life of Patients Suffering from Pain Predominant Medically Unexplained Physical Symptoms (MUPS)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pawan Goel 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  D2 Ward All India Institute of Medical Sciences Delhi 110029

New Delhi
DELHI
110088
India 
Phone  9999896637  
Fax    
Email  pawangoel0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pawan Goel 
Designation  Junior Resident Department of Medicine 
Affiliation  All India Institute of Medical Sciences 
Address  D2 WARD All India Institute of Medical Sciences Delhi 110029

South
DELHI
110088
India 
Phone  9999896637  
Fax  9999896637  
Email  pawangoel0@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Rita Sood 
Designation  Head and Professor Department of Medicine 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 4098 All India Institute of Medical Sciences Delhi 110029

South
DELHI
110029
India 
Phone  01126594998  
Fax    
Email  ritasood@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Supported by Department of Medicine and Centre for Integrative Medicine and Research 
Address  All India Institute of Medical Sciences Delhi 110029 
Type of Sponsor  Government medical college 
 
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 Pawan Goel  Medicine OPD Room No 32/33 AIIMS  All India Institute of Medical Sciences
South
DELHI 		 9999896637

pawangoel0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain predominant medically unexplained physical symptoms (MUPS)with Persistent pain (at least three months)which is not explained by any underlying medical condition. Initial PHQ score more than 18,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard therapy  Comparator agent will be the standard therapy provided to patients with Pain predominant medical unexplained symptoms which includes SSRIs and TCAs. For the purpose of the study Fluoxetine(upto 40mg) would be the drug used and the reference for the usage has been provided in the protocol . 
Intervention  Yoga program for 3months along with Standard Care  The intervention group would be taught yoga practices by a trained yoga therapist at CIMR , AIIMS over a period of 3 months. During the study duration the subjects will be invited to CIMR for contact classes.There will be 20 contact classes in the study period . there will be 5 supervised sessions in the first week followed by 4 supervised sessions per month till 3rd month. Each session will have a pre planned curriculum that will progressively be more challenging and which will facilitate adherence and secure repeatability of the intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with pain predominant medically unexplained physical symptoms (MUPS) with age group of 18- 60 years attending the OPD
2.Persistent pain (at least three months, continuously on most days) severe and distressing pain, in any part of the body.
3. Patients with initial PHQ score of at least 18
4. Residing within Delhi NCR and willing to follow up as per protocol
5. Willing to give written consent for participation in the study 
 
ExclusionCriteria 
Details  1. Age<18 years
2.Not suffering from any major psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in PHQ-15 scores from recorded baseline 2. Reduction in the WHODAS 2.0 score from recorded baseline 3. Improvement in WHOQOL score from previously recorded baseline   Follow up with scoring questionnaires will be done on 6weeks and at 12weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess socioeconomic correlates of the patients with medically unexplained physical symptoms .   Data recorded at baseline but analysed at the end of the study independent of the other primary outcome determinants 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/02/2018 
Date of Study Completion (India) 07/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/08/2019 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Post graduate thesis project. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This project is a randomized clinical trial to assess the efficacy of yoga on symptom severity and quality of life of patients suffering from Pain Predominant Medically Unexplained Physical Symptoms (with PHQ15>18 and pain lasting for more than 3months). After ruling out any underlying psychiatric illness Patients will be randomised into 2 groups with 1st group receiving only standard pharmacological interventions and the second group receiving yoga(for 12 weeks) in addition to pharmacological interventions. Patients baseline characteristics will be recorded using PHQ15(for severity of physical symptoms) , WHODAS and WHOQOL BREF(Quality of life and disability) and the same will be compared post intervention at 6weeks and 12weeks.
 
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