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CTRI Number  CTRI/2023/04/051302 [Registered on: 05/04/2023] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Adjuvant Yoga Therapy in Managing Withdrawal Symptoms of Patients with Opioid Use Disorder 
Scientific Title of Study   Role of Adjuvant Yoga Therapy in Managing Withdrawal Symptoms of Patients with Opioid Use Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suddala Goutham 
Designation  Post Graduate Student 
Affiliation  National Institute of Mental Health and Neuroscience. 
Address  New Yoga Centre Building, 3rd floor, Room no.2, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.

Bangalore
KARNATAKA
560029
India 
Phone  8332924301  
Fax    
Email  gouthamreddy148@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor of Yoga 
Affiliation  National Institute of Mental Health and Neuroscience. 
Address  First floor, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore, Karnataka 560029, India.
Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  yogaforstress.nimhans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Holla 
Designation  Assistant Professor of Psychiatry 
Affiliation  NIMHANS 
Address  First floor, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore, Karnataka 560029, India.
Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  hollabharath@gmail.com  
 
Source of Monetary or Material Support  
Department of Integrative Medicine, Yoga centre, NIMHANS, Bangalore, Karnataka 560027. 
 
Primary Sponsor  
Name  Dr. Suddala Goutham 
Address  3rd Floor, New Yoga Centre, Department of Integrative Medicine, NIMHANS. 
Type of Sponsor  Other [Self] 
 
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 Suddala Goutham  NIMHANS  CENTRE FOR ADDICTION MEDICINE, In-patient ward, NIMHANS, Bangalore, Karnataka 560027, India.
Bangalore
KARNATAKA 		 8332924301

gouthamreddy148@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in AYUSH and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Immediate effect of 10 minute pranyama technique on HRV in patients with Opioid use disorder who are currently experiencing acute withdrawal symptoms.  Immediate effect of one session of 10-minute pranayama technique will also be assessed. The pranayama technique will include 1) 5 minutes of Left nostril breathing in a sitting position in a ratio 1:2 for inhalation: exhalation 2) 5 minutes of gentle humming breath in a sitting down position tongue gently touched to the upper palate with eyes closed - attention on vibration of sound in the ears. With the instruction of turning consciousness inwards with each breath. It will be a continuous HRV recording.  
Comparator Agent  Sitting Relaxed  Just sitting relaxed for 10 min. Continuous HRV recording will be done.  
Comparator Agent  Treatment as usual  The control group doesnt receive any Yoga module, they just remain with treatment as-usual for 2 weeks. We will pre and post sleep quality, symptoms severity, Heart Rate Variability (HRV), Hamilton anxiety rating scale (HAM-A), Brief Pain Inventory (BPI) and Algometer for pain threshold.  
Intervention  Yoga Therapy and Treatment as usual  Yoga module for Substance use disorder during Acute withdrawal phase is given along with treatment as usual for the intervention group. The intervention is for 2 weeks days. During intervention period Yoga session will be conducted for a duration of 45 min, six days a week. We will take pre and post sleep quality, symptoms severity, Heart Rate Variability (HRV), Hamilton anxiety rating scale (HAM-A), Brief Pain Inventory (BPI) and Algometer for pain threshold.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Diagnosis of Opioid use disorder.
Subjects with mild to moderate severity of withdrawal symptoms (Clinical Opiate Withdrawal Scale: COWS score below 24).
Subjects who got admitted into CAM, NIMHANS and started on treatment. 
 
ExclusionCriteria 
Details  COWS score more than 25.
Patients not willing to give informed consent.
History of current medical illness that may significantly affect brain functions.
Patients with intractable pain due to other diseases and those on prescribed opioids for the pain of other medical conditions.
Impaired general intellectual functioning (Mini-Mental Status Exam, MMSE below 24).
Past history of head injury or concomitant severe medical conditions.
With co-morbid (alcohol/benzodiazepine/cannabis or multiple) substance dependence except nicotine.
Subjects who had received specific yoga practices for OUD in the past.
Pregnant or post-partum subjects.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability (HRV).
Symptoms severity assessed by Clinical Opiate Withdrawal Scale (COWS).
 		 Pre(0 days) and post(after 2 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep quality.
Perceived stress.
Hamilton anxiety rating scale (HAM-A).
Brief Pain Inventory (BPI) and Algometer for pain threshold.
 		 Pre(0 days) and post(after 2 weeks) 
Seeing the immediate effect of 10 minute pranyama technique on HRV in patients with Opioid use disorder who are currently experiencing acute withdrawal symptoms   It will be a continuous HRV recording. To see immediate effect. One time point. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2023 
Date of Study Completion (India) 08/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Patients diagnosed with opioid use disorder are assessed for severity of withdrawal symptoms using Clinical Opiate Withdrawal Scale (COWS). The patients with mild to moderate severity of withdrawal symptoms and taking buprenorphine for management of symptoms are randomized into two groups that is Yoga + standard treatment group and Treatment only group. Duration of intervention is 20 days. Clinical history will be done at baseline. Assessments will be done at the baseline and at the end of the intervention, for those who are willing to participate in the study. Safety assessments and adverse events will be monitored and appropriately documented for the duration of study period.  
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