Integrative Treatment using Ayurveda, Yoga and Psychopharmacological agents for Depression (INTRAP-D) - A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depression Score
研究概览
简要总结
Depression is one of the most common and severe psychiatric disorders with significant morbidity and mortality. The treatment for depression primarily involves use of anti-depressants and psychological interventions. However 20-30% of cases are resistant to known treatments and do not show adequate improvement [1, 2]. Integration of treatments is a well-known modality to overcome the limitations of any one particular type of treatment. Ayurveda is one of the oldest forms of treatment that originated in India treating various forms of physical and psychiatric disorders. These treatments may be in the form of body massages, specific diet and medications [3].This study aims to study the add-on effect of the Ayurveda and yoga in conjunction with standard psychiatric treatment. The study will have three arms, each of standard psychiatry treatment, standard Ayurveda treatment and the interventional arm which consists of add on Ayurveda and yoga to standard psychiatric treatment with follow up schedule till 6 months post recruitment. The outcome factors being the depression score, quality of life, clinical improvement and ADRs. Informed consent will be taken and standard institutional ethical guidelines will be adhered to. The major clinical implications of the study is in the use of Ayurveda and yoga in standard treatment of depression in reducing morbidity and improving the recovery rate. The study will also look into the molecular markers of improvement in depression. BDNF expression and the levels will be studied across the arms to determine the neurobiological changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •DSM V diagnosis of Major depressive disorder for all groups of patients Mild, moderate and severe severity Atleast one trial antidepressant treatment.
排除标准
- •Psychotic symptoms Active suicidal ideas Neurology diagnosis Unstable medical condition Substance use disorders subjects who are doing regular Yoga in control arm Drug naive cases of depression.
结局指标
主要结局
Depression Score
时间窗: 0, 2, 4, 8,12 weeks
BDNF level
时间窗: 0, 2, 4, 8,12 weeks
Quality Of life
时间窗: 0, 2, 4, 8,12 weeks
次要结局
- Adverse drug reactions(0, 2, 4, 8,12 weeks)
