Health Condition 1: G- Mental Health
Conditions
Interventions
Intervention1: Ksheerabala Taila: Dose- 450 ml once daily locally for Shiro Dhara,
Dosage form - Oil,
Route of Administration- External application over the head b
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subjects of either sex in the age group 18 - 60 years irrespective of socioeconomic status. 2)Patients diagnosed with depression based on the ICD-10 classification of mental disorders provided by the World Health Organisation and are currently experiencing a depressive episode of at least a 60-day duration at the time of screening. 3)Patients with score of 20 or higher on the Hamilton Depression Rating Scale (HDRS). 4)Willing to participate and able provide signed informed consent. [HDRS score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. A later 21-item version (HDRS21) included 4 items intended to subtype the depression, but which are sometimes, incorrectly, used to rate severity]. Reference: Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.
Exclusion criteria
Exclusion criteria: 1)Patients with poorly controlled Hypertension ( >160/100mm of Hg), Diabetes Mellitus (HbA1c >8.0), unstable cardio-vascular disease, concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or other concurrent severe disease, any concurrent renal disorders (S. Creatinine >1.2mg/dl), Patients with evidence of malignancy, with severe COPD, hypothyroidism or hyperthyroidism. 2)Patients with a history of stroke or Transient Ischemic Attack (TIA), epilepsy 3)Patients with schizophrenia spectrum or other psychotic disorders, OCD, PTSD, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder, antisocial personality disorder, aggressive impulses, or severe cognitive, language, or hearing deficits 4)Patients having the H/o concomitant other substance abuse, moderate or severe alcohol or drug use disorder. 5)Patients with Past suicide attempt, Active suicidal risk (history of suicide attempts to be evaluated on a case by case basis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of Changes in the scores of Hamilton Depression Rating Scale (HDRS) in Group I (Ayurvedic + Yoga + CBT+ Conventional) and Group II (Conventional+CBT) in the management of Depression.Timepoint: Baseline, Fifteenth Day, Thirtyth Day, Ninetyth Day, One Hundred Fifth Day, One Hundred Twentyth, One Hundred Fiftyth Day, One Hundred Eightyth Day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in of Quality of life as assessed through WHO QoL BREF questionnaire. 2. Change in Clinical global impression rating scale (Annexure – IV). 3. Assessment of Clinical Safety of study participants through laboratory investigations. 4. Proportion of study participants with Incidences of Treatment emergent AE/SAE 5. Assessment of tolerability of interventions 6. Assessment of intervention compliance.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr DipSundar Sahu
Central Ayurveda Research Institute, Kolkata
Outcome results
None listed