A pilot study of Virechanakarma in Major Depressive Disorder

Phase 3

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

• Registration Number: CTRI/2023/09/057916
• Lead Sponsor: Centre For Excellence, AYUSH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To examine the clinical effects of add-on virechanakarma in patients with MDD in <br/ ><br>comparison to Treatment As Usual Group (TAU). <br/ ><br>• To examine the S.CRP & S. Cortisol changes following add-on virechanakarma in <br/ ><br>patients with MDD in comparison to Treatment As Usual Group (TAU). <br/ ><br>• To examine the Metabolic changes (by measuring FBS & Lipid profile) following <br/ ><br>add-on virechanakarma in patients with MDD in comparison to Treatment As Usual <br/ ><br>Group (TAU)Timepoint: Baseline & 2 weeks