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Clinical Trials/CTRI/2023/09/057916
CTRI/2023/09/057916
Not Yet Recruiting
Phase 3

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

Centre For Excellence, AYUSH0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Centre For Excellence, AYUSH
Status
Not Yet Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Centre For Excellence, AYUSH

Eligibility 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

  • •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
  • •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

Outcomes

Primary Outcomes

Not specified

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