Health Condition 1: F432- Adjustment disorders
Conditions
Interventions
Intervention1: Itrifal Zamani and Raughan Kahu: 5g (semisolid) to be taken orally twice daily with water after meal and massage oil gently on the scalp with fingers for minimum 10 minutes at night res
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex 2. Age 18-65 years 3. Mild to Moderate Anxiety and Depression (as per Hamilton rating scale) 4. Patient fulfilling the following diagnostic criteria laid down by DSM IV (Diagnostic & statistical manual IV edition) for MADD. - Persistent or recurrent dysphoric mood for at least 1 month. - The dysphoric mood is accompanied by at least 1 month a of four (or more) of the following symptoms: 1. difficulty concentrating or mind going blank. 2. Sleep disturbance (difficulty falling asleep 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 10. Low self-esteem or feelings of worthlessness. - The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. - The symptoms are not a result of the direct physiological effects of a substance or a general medical condition. - All of the following: 1. Criteria have never been met for major depressive disorder, dysthymic disorder, panic disorder or GAD. 2. Criteria are not currently met for any other anxiety or mood disorder (including an anxiety or mood disorder in partial remission) 3. The symptoms are not better accounted for by any other mental disorder.
Exclusion criteria
Exclusion criteria: 1. Drug abuser or any medication causing direct psychological effect. 2. Patient having past history of major depressive disorder (including an anxiety or mood disorder, in partial remission) 3. Presence of any other mental disorder other than MADD. 4. Known cases of hyperthyroidism, CVD, renal and liver diseases. 5. Severe anxiety or depression according to the Hamilton Rating Scale. 6. Pregnancy and lactation. 7. Participation in another study or previous participation in same study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) will be used for the assessment of efficacy.Timepoint: At every 15 days for 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.Timepoint: At baseline and after 6 weeks | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed