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CTRI Number  CTRI/2025/07/089999 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Yoga can help in Opium addiction recovery: A study on holistic well being 
Scientific Title of Study   Efficacy of Integrated Yoga Therapy in Opium Abuse Recovery: A longitudinal randomized controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjib Patra 
Designation  Professor 
Affiliation  Central University of Rajasthan 
Address  Room No. 5, Yoga Research Division, Department of Yoga, Central University of Rajasthan, Kishangarh, Ajmer, Rajasthan 305817 India

Ajmer
RAJASTHAN
305817
India 
Phone  08618142265  
Fax    
Email  sanjib.patra@curaj.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Arjun Ram Roj 
Designation  PhD scholar 
Affiliation  Central University of Rajasthan, Bandarsindri, Rajasthan 
Address  Room No. 4, Yoga Research Division, Department of Yoga, Central University of Rajasthan, Kishangarh, Ajmer, Rajasthan 305817 India

Ajmer
RAJASTHAN
305817
India 
Phone  08302291438  
Fax    
Email  2023phdyg001@curaj.ac.in  
 
Details of Contact Person
Public Query  
Name  Arjun Ram Roj 
Designation  PhD scholar 
Affiliation  Central University of Rajasthan, Bandarsindri, Rajasthan 
Address  Room No. 4, Yoga Research Division, Department of Yoga, Central University of Rajasthan, Kishangarh, Ajmer, Rajasthan 305817 India


RAJASTHAN
305817
India 
Phone  08302291438  
Fax    
Email  2023phdyg001@curaj.ac.in  
 
Source of Monetary or Material Support  
CENTRAL UNIVERSITY OF RAJASTHAN NH-8, Bandar Sindri, Dist-Ajmer-305817, Rajasthan [INDIA] 
 
Primary Sponsor  
Name  Central University of Rajasthan 
Address  Central University of Rajasthan, NH-8, Bandar Sindri, Dist-Ajmer-305817, Rajasthan [INDIA] 
Type of Sponsor  Other [Central University of Rajasthan, A Central Government University] 
 
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 Sanjib Patra  Central University of Rajasthan  Room No. 4, Yoga Research Division, Department of Yoga, Central University of Rajasthan, Kishangarh, Ajmer, Rajasthan 305817 India RAJASTHAN 305817 India
Ajmer
RAJASTHAN 		 08618142265

Sanjib.patra@curaj.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central University of Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male participants with opium dependence 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Treatment for opioid addiction  Standard treatment alone comprising the Opioid Substitution Therapy (OST) without any other add on intervention. 
Intervention  Standard treatment with Integrated Yoga Therapy  Standard treatment comprising Opioid Substitution Therapy with 3 months of Integrated Yoga Therapy intervention, comprising Shatkarma, Sukshma and sthula vyayama, Asana, Pranayama and meditation as add on treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  a) Diagnosis of OUD (DSM 5 criteria)
b) Score greater than 3 on Clinical Global Impression Severity (CGIS)
c) Age range 18 to 60 years
d) Male
e) Written informed consent
f) Geographical Location Residents of rural western Rajasthan

 
 
ExclusionCriteria 
Details  a) Severe withdrawal symptoms (COWS greater than 25)
b) other diseases causing intractable pain.
c) Prescription opioids for pain related to her medical conditions
d) Comorbid alcohol, benzodiazepine, cannabis, etc., multiple substance dependence in last six months except for nicotine
e) Impaired intellectual functioning (HMSE more than 24)
f) Severe psychiatric or medical illness preventing practice of the yoga program
g) Risk of harm to self or others
h) Current or recent practice of yoga (more than 4hr per month in last three months)
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Abstinence: Proportion of participants with opioid-negative urine tests at 3 months and 6 months post-intervention.

Craving: Change in scores on the Craving Questionnaire (CCQ) from baseline to 3
months and 6 months. 		 Baseline - 3 Months and 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Psychological Well-being: Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Depression Anxiety Stress Scales - Short Form (DASS-21), World Health Organization Quality of Life - BREF(WHOQOL-BREF), Beck Hopelessness Scale (BHS), Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2).  Baseline - 3 Months and 6 Months 
Physiological Health: Heart Rate Variability (HRV), spirometry, Gut Dysmotility Questionnaire (GDQ), Constipation Scoring System (CSS), Bristol Stool
Form Scale (BSFS), o Patient Assessment of Constipation-Symptoms (PAC-SYM), o Bowel Function Index (BFI)  		 Baseline - 3 Months and 6 Months 
Biochemical markers: cortisol, beta-endorphins, osteocalcin, prolactin,
luteinizing hormone (LH), testosterone, dopamine, serotonin, adrenocorticotropic hormone (ACTH), and routine serum markers. 		 Baseline - 3 Months and 6 Months 
Sensory Function Recovery: Tinnitus Handicap Inventory, Taste Strips Test, Chemosensory Questionnaire (CPQ), Quality of Vision (QoV) Questionnaire.
 		 Baseline - 3 Months and 6 Months 
Withdrawal Symptoms and Adverse Effects: Clinical Opiate Withdrawal Scale (COWS), Udvalg for
Kliniske Undersogeleser (UKU) Side Effects Rating Scale. 		 Baseline - 3 Months and 6 Months 
Behavioral and Cognitive Enhancement: Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index, Buss-Perry Aggression Scale (BPAQ), cognitive tests (Five-Point
Test, Digit Span, Spatial Span, Stroop Color-Word Interference Test, Game
of Dice Task), Social Occupational Functioning Scale (SOFS).  		 Baseline - 3 Months and 6 Months 
Sustainability of Therapeutic Benefits: : Relapse rates defined as return to opioid use, confirmed
by urine drug screens or self-reported via Time-Line Follow Back (TLFB). 		 Baseline - 3 Months and 6 Months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/08/2025 
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="0"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Globally, over 35 million people suffer from substance use disorders, with opioids, including opium, contributing to approximately 500,000 deaths annually, including 80,000 from respiratory depression in the US alone (WHO). In India, 22.6 million individuals need treatment for substance abuse, with Western Rajasthan reporting high opium addiction rates (up to 8.4% in Barmer) (National Survey). Opium addiction causes cognitive decline, hypogonadism, respiratory depression, insomnia, QT prolongation, and osteopenia/osteoporosis, severely impacting overall health and socio-economic stability. This urgent study addresses the escalating opium addiction crisis in rural India, where conventional treatments show limited success. By leveraging Integrated Yoga Therapy (IYT) comprising Shatkarma, Sukshma and sthula vyayama, asana, pranayama, and meditation, a culturally resonant and cost-effective intervention, it aims to mitigate severe health complications, reduce relapse, and enhance recovery, potentially shaping scalable addiction treatment strategies.

 
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