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CTRI Number  CTRI/2023/07/054596 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Vamana Dhauti as an add on treatment in Depression- a Pilot RCT  
Scientific Title of Study   Feasibility and Tolerability of Vamana Dhauti as an add-on treatment in patients with Depression: a Pilot Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Garg 
Designation  Post graduate student  
Affiliation  NIMHANS  
Address  Third floor, New yoga building, Department of Integrative Medicine, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  8197724152  
Fax    
Email  draditigargnaturo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kishore Kumar Ramakrishna  
Designation  Head of Department and Guide  
Affiliation  NIMHANS 
Address  First floor, Ayurveda block, Department of Integrative Medicine

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  ayurkishore@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kishore Kumar Ramakrishna  
Designation  Head of Department and Guide  
Affiliation  NIMHANS 
Address  First floor, Ayurveda block, Department of Integrative Medicine

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  ayurkishore@yahoo.com  
 
Source of Monetary or Material Support  
Department of Integrative Medicine,National Institute of MentalHealth and Neuroscience  
 
Primary Sponsor  
Name  Dr Aditi Garg 
Address  Third floor, New yoga building, 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 Aditi Garg  National Institute of Mental Health and Neurosciences   Department of Integrative Medicine, NIMHANS
Bangalore
KARNATAKA 
8197724152

draditigargnaturo@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: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (4) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (5) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (6) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (7) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (8) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (9) ICD-10 Condition: F30-F39||Mood [affective] disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Shavasana only   Shavasana rest only on day one followed by six days of yoga practice from day two to day seven  
Intervention  Vamana Dhauti  Vamana Dhauti once on day one followed by Shavasana rest and six days of yoga practice from day two to day seven  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients diagnosed with depressive disorder according to ICD11 or DSM V - TR
Patients with stable medications for the last one month  
 
ExclusionCriteria 
Details  Any present diagnosis of gastric or duodenal ulcers, Hypertension, Cardiovascular disorders, Alcohol use associated with oesophageal varices, hernia, pregnant women, Co-morbidities like Diabetes associated with increased intra ocular pressure
Patients practising yoga, meditation or any mind body practice in last one month
Patients with risk of harm
Patients not willing to participate in the study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Feasibility, tolerability of Vamana Dhauti
HRV changes at baseline, during and after the procedure (day 01) 
At baseline, after the procedure (day01) 
 
Secondary Outcome  
Outcome  TimePoints 
HDRS-17 scores   Baseline and after seven days  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 1/ Phase 2 
Date of First Enrollment (India)   10/07/2023 
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="1"
Months="0"
Days="0" 
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   Patients will be recruited according to eligibility criteria and randomly divided into two groups. One group will be given Vamana Dhauti on day one followed by Shavasana rest whereas the other group will be given Shavasana rest. After this both will be given yoga practice (validated yoga protocol from previous studies) for six days (day two to day seven)
At baseline HDRS-17 will be administered and HRV will be measured. On day one - HRV will be continuously measured during Vamana Dhauti and Shavasana. After seven days HRDS-17 will be again evaluated. 
 
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