Effectiveness of Ashwagandha (Withania somnifera (L.) Dunal) In The Management Of Vishaada (Mild To Moderate Depressive Disorder) Among Adolescents: A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Reduction in the PHQ-9 score.
研究概览
简要总结
Mental health is a part of overall health and well-being. It includes all the aspects viz. emotional, psychological as well as social well-being. Mental health is important at every stage of life, from childhood and adolescence through adulthood. The mental health services are the most neglected area among existing health care services. Inaccurate-assessment, lack of trained health-care providers and resources, lack of awareness, paucity of mental health specialists, low-socio-economic conditions and a social stigma of being managed for a mental health condition are the factors associated with its negligence. Promoting and protecting adolescents’ mental health will lead to great public health, economic and demographic benefits along with triple dividend health benefits – for adolescents now, for adolescents’ future lives and for the next generation too. Promotion of good sleeping and dietary habits, early detection and management of common problems (mental as well as social and sexual) may provide long term healthy lifestyle and morbidity and premature mortality may be reduced in adulthood.
Considering the spectrum of the problem, the present study has been undertaken with a solution of improving adolescents’ mental health conditions as well as their quality of life.
**HYPOTHESIS:**Clinical symptoms of Depression are reduced with improvement in sleep and quality of life in adolescents aged 10-16 years, diagnosed with mild to moderate depressive disorder who receive oral administration of aqueous extract of Ashwagandha (Withania somnifera (L.) Dunal) root 250mg per day in two divided doses (1 Capsule of 125mg twice daily) with lukewarm water along with counselling therapy for duration of 8 weeks compared with those who receive placebo with counselling therapy with identical doses and periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Reduction in the PHQ-9 score.
时间窗: Before Treatment-After Treatment (8weeks)
次要结局
- Improvement in sleep quality of adolescents.(Improvement in Clinical Global Impression Score.)
