Health Condition 1: F413- Other mixed anxiety disorders
Conditions
Interventions
Intervention1: Habb-e-Ikhtilaj: Two tablets (1 gm each) taken orally twice daily with water after meals for 6 weeks (42 days).
Control Intervention1: Majoon-e-Najah: 5 gm taken orally twice daily with
Sponsors
Central Council for Research in Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically significant distress or impairment in social, occupational or other important areas of functioning. 2.Patients falling in the category of mild to moderate anxiety and depression-according to Hamilton rating scale. 3. Patients fulfilling the diagnostic criteria laid down by DSM-IV for MADD i.e. Patients with persistent or recurrent dysphoric mood lasting at least one month companied by four or more following symptoms for at least one month: i. Fatigue or low energy ii. Low self-esteem or feeling of worthlessness iii. Difficulty concentrating or mind going blank iv. Sleep disturbance (difficulty falling or staying asleep or restless, unsatisfying sleep v. Being easily moved to tears vi. Anticipating the worst vii. Hopelessness viii. Worry ix. Hyper vigilance x. Irritability
Exclusion criteria
Exclusion criteria: 1. Patients having severe anxiety or depression according to Hamilton rating scale (especially with suicidal ideation) 2. Drug abuser or any medication causing direct psychological effect. 3. Patient having past history of major depressive disorder (including an anxiety or mood disorder, in partial remission) 4. Presence of any mental disorder other than MADD. 5. Patients with diseases requiring long term treatment Known cases of hyperthyroidism, CVD, renal and liver diseases. 6. Severe anxiety or depression according to the Hamilton Rating Scale. 7. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the signs and symptoms of Malankhuliya (Mixed Anxiety Depressive Disorder). Which will be assessed on the basis of Hamilton s Anxiety rating scale and Hamilton s Depression rating scale.Timepoint: At baseline, on 1st follow-up, 2nd follow-up and end of the protocol therapy. (i.e., 0, 2nd, 4th and 6th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.Timepoint: At baseline, on 1st follow-up and end of the protocol therapy. (i.e., 0, 2nd and 6th week) | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed