Role of Ashwagandha in the management of Mild to Moderate Depression among adolescents
- Conditions
- Health Condition 1: F330- Major depressive disorder, recurrent, mildHealth Condition 2: F331- Major depressive disorder, recurrent, moderate
- Registration Number
- CTRI/2021/11/037967
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants showing signs of Mild to Moderate Depression as per DSM-V Criteria. (PHQ-9 score 5-14).
Participants providing written informed consent of caretakers/parents.
Participants providing written informed assent to participate in the study.
No Depression (PHQ- 9 score below or equals to 4) along with no other clinical manifestation.
Severe Depression (PHQ- 9 score equal or above 15).
Intelligent Quotient (IQ) Below 70 [Borderline Intelligence].
Any severe co-morbid psychiatric disorder, especially a diagnosis of bipolar disorder, schizophrenia, autism spectrum disorder, schizoaffective disorder or organic psychiatric disorder assessed by taking detailed history and examination.
Any other medical or neurological conditions or any other illness interfering with interventions.
Participants suffering from any systemic illness, history of epilepsy or chronic illness like hypo or hyperthyroidism.
Substance use disorder or dependency, suicidal ideations.
Current use of Anti-epileptics, anti-psychotic or psychotropic drugs (e.g., Selective Serotonin Reuptake Inhibitor, Serotonin and norepinephrine reuptake inhibitors etc.) and any other investigational drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the PHQ-9 score.Timepoint: Before Treatment-After Treatment (8weeks)
- Secondary Outcome Measures
Name Time Method Improvement in sleep quality of adolescents. <br/ ><br>Improvement in Clinical Global Impression Score. <br/ ><br>Improvement in the quality of life (QOL)Timepoint: Before Treatment-After Treatment (8weeks)