A Randomised Controlled Clinical Trial Of Medhya Effect Of Shalaparni (Desmodium gangeticum (L.) DC) Churna With Ashwagandha (Withania somnifera (L.) Dunal) Churna In Anavasthita Chitta In Perspective Of Generalized Anxiety Disorder in Adult Population.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Decrease in the symptoms of anxiety and reduction of score (HAM-A Scale) by 50% or more
研究概览
简要总结
The primary objective of this open-labelled, randomized controlled clinical trial is to assess the effect of Shalaparni (Desmodium gangeticum (L.) DC) churna with respect to Ashwagandha churna for the management of Anavasthita Chitta in perspective of Generalized Anxiety Disorder.
The secondary objectives are:
- To collect a genuine sample of Shalaparni (Desmodium gangeticum (L.) DC) and to study its pharmacognostic and physicochemical properties.
- To study the cultivation practices of Shalaparni and to cultivate it as per feasibility.
A total of 46 participants between the ages of 20 and 40 years, having moderate to severe anxiety as per the GAD-7 scale, will be selected for the study. They will be randomly allocated into two groups. Participants in Group A will receive the study drug, i.e., Shalaparni churna, and participants in Group B will receive the control drug, i.e., Ashwagandha churna.
Assessment will be carried out using the Hamilton Anxiety Rating Scale (HAM-A) at the beginning of the study. Participants will then receive the respective drugs, to be taken for a duration of two months. Reassessment using the HAM-A scale will be conducted at the end of two months. An improvement of 50% or more in the HAM-A score will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be selected irrespective of gender with age between 20-40 years, fulfilling criteria for generalized anxiety disorder given in the Diagnostic and Statistical Manual of Mental Disorders.
排除标准
- •Participants with known case of any serious illness (cardiac, hepatic, renal disease, respiratory disorder, cancer etc.) Participants with known case of Mental retardation or having any other psychiatric treatment Pregnant or lactating woman.
结局指标
主要结局
Decrease in the symptoms of anxiety and reduction of score (HAM-A Scale) by 50% or more
时间窗: Every 15 days for 2 months
次要结局
- Evaluating any other effect of shalaparni clinically(2 months)
研究者
Vd Shivangi Vinay Bodas
Tilak Ayurved Mahavidyalaya, Pune