Health Condition 1: F438- Other reactions to severe stress
Conditions
Interventions
Intervention1: Majoon Najah: 5gm Twice daily Orally with water for six weeks
Control Intervention1: Nil: Nil
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in sign and symptoms of MÄ?lankhÅ«liya (Mixed Anxiety Depressive Disorder)Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical assessment for safety assessmentTimepoint: Investigations will be done at baseline and end of treatment | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed