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Clinical Trials/CTRI/2020/02/023429
CTRI/2020/02/023429Not yet recruitingPhase 3

Clinical Validation of Unani Pharmacopoeial Formulation Majoon Najah in MÄ?lankhÅ«liya (Mixed Anxiety Depressive Disorder)

Central Council for Research in Unani Medicine CCRUM New Delhi0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1. Patients of either sex between the age group of 18-60 years
  • •2. Patients fulfilling the diagnostic criteria laid down by DSM IV (Diagnostic and Statistical Manual IV edn.) for MADD.
  • •a)Patients with persistent or recurrent dysphoric mood lasting at least one month.
  • •b)Accompanied by at least one month of four (or more) of the following symptoms:
  • •i.Difficulty concentrating or mind going blank
  • •ii.Sleep disturbance (difficulty falling or staying asleep or restless, unsatisfying sleep.
  • •iii.Fatigue or low energy
  • •iv.Irritability
  • •vi.Being easily moved to tears
  • •vii.Hyper vigilance
  • •viii.Anticipating the worst
  • •ix.Hopelessness
  • •x.Low self-esteem or feeling of worthlessness
  • •3. Clinically significant distress or impairment in social, occupational or other important areas of functioning.
  • •4. Patients falling in the category of mild to moderate anxiety and depression-according to Hamilton rating scale

Exclusion Criteria

  • •1.Patients on drug abuse or any medication causing direct psychological effects.
  • •2.Symptoms due to general medical condition or any organic cause of disease.
  • •3.Patients having past history of major depressive disorder (including an anxiety or mood disorder, in partial remission).
  • •4.Presence of any other mental disorder.
  • •5.Patients having severe anxiety or depression according to Hamilton rating scale (especially with suicidal ideation)
  • •6.Presence of any other mental disorder.
  • •7.Patients having severe anxiety or depression according to Hamilton rating scale (especially with suicidal ideation)
  • •8.Pregnancy and lactation.
  • •9.Participation in another study or previous participation in similar study.
  • •10.Known circumstances that make it difficult for the patients to administer study drug and / or result in failure to turn up for the follow up visit.

Investigators

Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi

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