Treatment of symptoms of both anxiety and depression with Unani medicine Itrifal Aftimoo
- Conditions
- Health Condition 1: F413- Other mixed anxiety disorders
- Registration Number
- CTRI/2023/06/053936
- 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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of the study drug will be assessed on the basis of improvement in symptoms of <br/ ><br>MÄ?lankhÅ«liya (Mixed Anxiety Depressive Disorder) for which 14 item Hamiltonâ??s Anxiety <br/ ><br>Rating Scale (HAM-A) and 17 items Hamiltonâ??s Depression Rating Scale (HDRS) will be <br/ ><br>used, and score will be noted.Timepoint: After every 14 days i.e. at 14, 28, 42 and 56 day.
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessmentTimepoint: At baseline, 2 weeks and 8 weeks