CTRI/2025/03/083674尚未招募2/3 期
Randomized control trial to evaluate the effect of Viddha karma at Unmad Marma points in Generalized Anxiety Disorder cases
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- changes in symptoms of GAD
研究概览
简要总结
160 cases of mild GAD will be included in this interventional study which will be randomly divided into 4 groups of 40 patients in each group. First group will be prescribed Standard treatment of anxiolytic drug Paroxetine along with standard viddha karma. Second group will be prescribed placebo with standard viddha karma. Third group will be prescribed with Standard treatment of anxiolytic drug Paroxetine along with viddha karma at placebo points. Fourth group will be placebo along with viddha karma at placebo points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Meeting the International Classification of Diseases (ICD-11) criteria for Generalized Anxiety Disorder with a diagnosis of anxiety validated by 2 scales 2 Willing to complete daily diary.
- •3 Willing to take the Viddha Therapy study for 60 days.
排除标准
- •1 Age below 18 and 40 above years 2 Moderate to severe (25-30) degree cases in accordance with GAD-7 and HAMA score.
- •3 People living with psychiatric disorders in the spectrum of schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder substance-related disorders, and addictive disorders 4 Major medical illnesses under treatment such as Tuberculosis, AIDS, Malaria, Hypertension, Diabetes mellitus etc.
- •5 Pregnancy 6 Comorbid condition 7 Patient not willing to give his/her consent.
结局指标
主要结局
changes in symptoms of GAD
时间窗: change in the GAD-7 and HAMA scoring after every week for eight week
次要结局
- Reduction in scoring of following scales-(1 HAM-A Score)
研究者
Dr Prachi Jain
Institute of Medical Sciences
研究点 (1)
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