A pilot study of Virechanakarma in Major Depressive Disorder

Phase 3

Not yet recruiting

Conditions: Major depressive disorder, recurrent, moderate. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA),

Registration Number: CTRI/2023/09/057916

Lead Sponsor: Centre For Excellence, AYUSH

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Between 18 to 60 years of age.
All genders.
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 â€“ 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.
Patients suitable for Virechana 6.
Willing to give informed consent.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the baseline Cardiac Autonomic Function & Neurohemodynamic	Baseline, 2 weeks
parameters in patients with MDD in comparison to Healthy people by measuring	Baseline, 2 weeks
HRV & fNIRS of Dorsolateral Prefrontal Cortex.	Baseline, 2 weeks
â€¢ To examine the change in Cardiac Autonomic Function & Neurohemodynamic	Baseline, 2 weeks
parameters following add-on virechanakarma in patients with MDD in comparison	Baseline, 2 weeks
to Treatment As Usual Group (TAU)	Baseline, 2 weeks

Secondary Outcome Measures

Name	Time	Method
To examine the clinical effects of add-on virechanakarma in patients with MDD in	comparison to Treatment As Usual Group (TAU).

Trial Locations

Locations (1): NIMHANS
🇮🇳
Bangalore, KARNATAKA, India
NIMHANS
🇮🇳Bangalore, KARNATAKA, India
DrKishore Kumar R
Principal investigator
9845829174
ayurkishore@yahoo.com