A pilot study of Virechanakarma in Major Depressive Disorder

A Pilot study examining the Neurobiological correlates of Virechanakarma in Patients with Major Depressive Disorder - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057916

Enrollment

Registered

2023-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F331- Major depressive disorder, recurrent, moderate

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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)Timepoint: Baseline, 2 weeks	—

Measure

Time frame

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)Timepoint: Baseline, 2 weeks

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Secondary

Measure	Time frame
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)Timepoint: Baseline & 2 weeks	—

Measure

Time frame

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)Timepoint: Baseline & 2 weeks

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Countries

India

Contacts

Public ContactDrKrishnaja

National Institute of Mental Health and Neuro Sciences

ayurkishore@yahoo.com9845829174

Outcome results