跳至主要内容
临床试验/CTRI/2020/03/024060
CTRI/2020/03/024060尚未招募不适用

Integrative Treatment using Ayurveda, Yoga and Psychopharmacological agents for Depression (INTRAP-D) - A pilot study

Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月6日最近更新:

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)

研究者

申办方类型
Private medical college

研究点 (1)

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