Health Condition 1: null- Depression
Conditions
Interventions
Intervention1: Test formulation 500mg twice per day for a period of 6 months: The standard hydro-alcoholic extract of four plants namely Nyctanthes arbortristis (137.5mg), Ocimum tenuiflorum (125mg),
Sponsors
Department of Science Technology
Dr H S Gill
Eligibility
Inclusion criteria
Inclusion criteria: 1.Have had depressive symptoms for a level â?? one month prior to screen visit. 2.Feeling of minimum three or more clinical symptoms like â?? evidence of low mood, sadness, emptiness, hopelessness , helplessness, worthlessness, feeling of guilt, irritable, anxious, worried, restlessness. 3.Depressed subjects must score on (18) on the HAM-D at screening visit and MRI screening session. 4.Hindi Speaking/local language Diagnosed depression patients willing to participate in clinical trial program. Those depression patients showed clinical symptoms like lack of interest, poor concentration, pessimistic thinking, early fatigability, poor sleep, poor appetite, weight loss, psychomotor retardation. The screening of depression patients were carried out on Hamilton Psychiatric rating Scale (DSM-IV).
Exclusion criteria
Exclusion criteria: 1.Any history of seizures 2.Diabetes requiring insulin treatment 3.A serious heart disorder/heart attack within the last 3 months 4.Subjects who meet DSM-IV criteria for alcohol /drug abuse or dependence within the last six months 5.Other current DSM-IV Axis I or Axis II diagnoses 6.A personal or family history of bipolar disorder 7.Current use of medication that affects CNS function 8.Participation in last 30 days in study involving an investigational drug 9.A subject with metallic implants, such as prostheses, shrapnel or aneurysm clip-S, or persons with electronic implants, such as cardiac pacemakers 10.A subject who is claustrophobic 11.Females who are pregnant, trying to become pregnant/not using birth control 12.A subject at serious risk for suicide 13.Had a diagnosis of cancer in the past 3 years and/or has active neoplastic disease 14.Non-response to 2 adequate trials of antidepressant treatment 15.Non-response to 2 adequate trials of an empirically supported psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in clinical complaints like elevation in mood, improvement in cognitive function including attention span, improvement in sleep along with regulation of biogenic amines.Timepoint: Gradual improvement (1 month to 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in appetite and body weight, better feeling of well being, reduced anxiety and improve early fatigueTimepoint: Gradual improvement (1 month to 6 months) | — |
Countries
India
Contacts
Public ContactDr Aruna Agrawal
Adesh Institute of Medical Sciences and Research
Outcome results
None listed