MedPath

Treatment of Depressive Disorder by Unani medicine Majoon Najah

Phase 3
Conditions
Health Condition 1: F438- Other reactions to severe stress
Registration Number
CTRI/2020/02/023429
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

v.Worry

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in sign and symptoms of MÄ?lankhÅ«liya (Mixed Anxiety Depressive Disorder)Timepoint: 6 weeks
Secondary Outcome Measures
NameTimeMethod
Haematological and biochemical assessment for safety assessmentTimepoint: Investigations will be done at baseline and end of treatment
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