Health Condition 1: F413- Other mixed anxiety disorders
Conditions
Interventions
Intervention1: Itrifal Aftimoon: 10 gm(semisolid) orally to be taken once daily with water at bedtime for 8 weeks
Control Intervention1: NIL: NIL
Sponsors
Central Council for Research in Unani Medicine (CCRUM), New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients fulfilling the Diagnostic Criteria for Mixed Anxiety-Depressive Disorder (MADD) as per DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) A. Persistent or Recurrent Dysphoric Mood lasting at least one month B. Dysphoric Mood is accompanied by at least one month of four (or more) of the following symptoms: 1. Difficulty concentrating or mind going blank 2. Sleep disturbance (difficulty falling or staying asleep, or restless unsatisfying sleep) 3. Fatigue or low energy 4. Irritability 5. Worry 6. Being easily moved to tears 7. Hypervigilance 8. Anticipating the worst 9. Hopelessness (pervasive pessimism about the future) 10. Low self-esteem or feelings of worthlessness C. Symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning 2. Mild to Moderate Anxiety and Depression (as per Hamilton rating scale)III. Patients of any sex in the age group of 18-60 years
Exclusion criteria
Exclusion criteria: 1. Severe Anxiety or Depression as per Hamilton Rating Scale (especially with suicidal ideation) 2. Dementia 3. Symptoms due to any organic cause of disease 4. Known cases of Cancer, severe hepatic, renal or cardiac ailments 5. Diabetes Mellitus 6. H/o addiction (Alcohol, drugs) 7. Pregnancy and Lactation 8. Presence of any other Mental Disorder 9. Participation in another study or previous participation in similar study 10. Inability to administer study drug and / or to come for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the study drug will be assessed on the basis of improvement in symptoms of MÄ?lankhÅ«liya (Mixed Anxiety Depressive Disorder) for which 14 item Hamiltonâ??s Anxiety Rating Scale (HAM-A) and 17 items Hamiltonâ??s Depression Rating Scale (HDRS) will be used, and score will be noted.Timepoint: After every 14 days i.e. at 14, 28, 42 and 56 day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical assessment for safety assessmentTimepoint: At baseline, 2 weeks and 8 weeks | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed