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CTRI Number  CTRI/2023/09/057916 [Registered on: 21/09/2023] Trial Registered Prospectively
Last Modified On: 17/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A pilot study of Virechanakarma in Major Depressive Disorder 
Scientific Title of Study   A Pilot study examining the Neurobiological correlates of Virechanakarma in Patients with Major Depressive Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnaja  
Designation  Junior Resident 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Dr Krishnaja Junior Resident Department of Integrative Medicine NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  9562648458  
Fax    
Email  krishnajakrishnasree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKishore Kumar R 
Designation  Professor & Head Of the Department 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Dr Kishore Kumar R Professor & Head Of the Department Department of Integrative Medicine NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrKrishnaja 
Designation  Junior Resident 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  DrKrishnaja Junior Resident Department of Integrative Medicine NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  9562649458  
Fax    
Email  krishnajakrishnasree@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences 
 
Primary Sponsor  
Name  Centre For Excellence, AYUSH 
Address  Centre For Excellence, AYUSH Department of Integrative Medicine NIMHANS  
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 
DrKishore Kumar R  NIMHANS  G-13 OPD, Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road 560029 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9845829174

ayurkishore@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: ASHTANGA HRIDAYA, Procedure details: VIRECHANA KARMA / MAX 15 DAYS)
(1) Medicine Name: MAHAPANCHAGAVYA GRITHA, Reference: ASHTANGA HRIDAYA, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Between 18 to 60 years of age.
2. All genders.
3. Diagnosed case of unipolar depression as per DSM 5
4. Patients who have not responded (Subjective improvement less than 50% / HDRS scale
less than 50% reduction in score / CGI – severity score more than or equal to 4 or CGI
global improvement score at the end of 4 weeks is more than or equal to 3) to 4 weeks of
first Antidepressant trial.
5. Patients suitable for Virechana
6. Willing to give informed consent. 
 
ExclusionCriteria 
Details  1. Patients who are on Tricyclic Antidepressants
2. Patients with any co -morbid axis I psychiatry disorders (except for nicotine dependence
syndrome), major systemic illness, neurological disorders and immune systemdisorders
3. Patients with active suicidal tendencies / attempts or uncooperative for assessments and
procedure
4. Pregnant and lactating mothers
5. Patients unsuitable for Virechana procedure
6. Patients with uncontrolled diabetes mellitus, hypertension, severe hepatic, renal or
pulmonary dysfunction
7. Patients who have undergone Virechana in the last 1 month 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To examine the baseline Cardiac Autonomic Function & Neurohemodynamic
parameters in patients with MDD in comparison to Healthy people by measuring
HRV & fNIRS of Dorsolateral Prefrontal Cortex.
• To examine the change in Cardiac Autonomic Function & Neurohemodynamic
parameters following add-on virechanakarma in patients with MDD in comparison
to Treatment As Usual Group (TAU) 		 Baseline, 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To examine the clinical effects of add-on virechanakarma in patients with MDD in
comparison to Treatment As Usual Group (TAU).
• To examine the S.CRP & S. Cortisol changes following add-on virechanakarma in
patients with MDD in comparison to Treatment As Usual Group (TAU).
• To examine the Metabolic changes (by measuring FBS & Lipid profile) following
add-on virechanakarma in patients with MDD in comparison to Treatment As Usual
Group (TAU) 		 Baseline & 2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 4 
Date of First Enrollment (India)   27/09/2023 
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="2"
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  
Depression is the most common psychiatric disorder in the world population and the most
frequent mental disorder in a primary health care. Depressive disorders are characterized by
sadness, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or
appetite, feelings of tiredness, and poor concentration. Major depressive disorder (MDD) is
analogous to a disease condition described in Ayurveda as Vishada. Vishada is a condition
characterized by global reduction in activities of mind, sensory faculties and body arising out of
disequilibria in doshas. Vishada has been mentioned as an extraordinary disease of the vata.
Ayurveda literature has dealt with the disease and its management comprehensively. Clinically
apart from vata dosa , involvement of kapha & pitha are also seen in patients of Major depressive
disorders like reduced energy levels , increased fatiguability , loss of appetite , diurnal variation
of worsening in morning hours ,dullness , withdrawal , disgust , anxiety etc,. In the combination
of tridosa, kapha need to be addressed first, then pitha and then vata. For kaphapitha hara
virechana is the best sodhana therapy advised as per Ayurveda literature. Recent study
demonstrates a positive influence of ayurvedic therapy on psychopathology, cardiac autonomic
function and endocrinal parameters in patients with depression. Clinically, we have found

considerable improvement in mood symptoms after a course of sodhana therapy. Sodhana can be
an adjunct in treating mood disorders. No published literature on efficacy of virechana in Mood
disorders are there, despite being classically recommended in texts. Neurobiological correlates of
virechanakarma in neuropsychiatric disorders is not studied making it a novel effort. Hence, this
study aims to understand the neurobiological correlates of virechanakarma in patients with
MDD.
It is a randomised control trial study which will assess changes in clinical parameters, cardiac
autonomic function(HRV), neurohemodynamic parameters(fNIRS), physiological
parameters(CRP , S.Cortisol) and metabolic parameters(FBS & Lipid profile) after the
intervention.
 
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