A pilot study to evaluate the efficacy of tablet ANXO-125 in the management of generalized anxiety disorder (GAD).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- effectiveness of treatments in reducing symptoms mentioned in GAD scale.
研究概览
简要总结
This study aims to evaluate the efficacy of tablet Anxo 125 in Generalised Anxiety Disorder (GAD) . Anxo-125 tablet is a formulation designed to address the pervasive issue of anxiety disorders, offering an approach to symptom management. The extensive therapeutic effect of medicine is a cornerstone for the formulation of Anxo-125 tablet, a medication that includes Trilokya vijaya vati, Mandukparni, Jatamansi, Haritaki, and Guduchi for the management of anxiety disorders. Patients will be recruited after screening through Gad-7 scale and given with tablet Anxo 125 in 2 OD dosage at night after food. Then after treatment follow up will be done and conclusion will be drawn after statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed anxiety disorder.
- •Willingness to comply with study requirements and follow instructions.
- •Absence of significant cognitive impairment or comorbid psychiatric disorders.
- •Ability to provide informed consent.
- •Stable medication regimen for other medical conditions for at least 4 weeks prior to the.
排除标准
- •Individuals with known allergies to the contents of Drug.
- •Pregnant or breastfeeding women.
- •Individuals with associated comorbidities Recent participation in another clinical trial.
- •Presence of severe medical conditions or unstable psychiatric disorders.
- •Current substance abuse or dependence.
- •Use of medications known to interact with the study drug Significant medical illness or unstable medical condition.
- •Use of other anxiolytic medications within the past 4 weeks.
- •Inability to comprehend or effectively communicate in the primary language of the study.
结局指标
主要结局
effectiveness of treatments in reducing symptoms mentioned in GAD scale.
时间窗: effectiveness of treatments in reducing symptoms mentioned in GAD scale in one month.
次要结局
- Monitoring for adverse effects such as Exacerbation of anxiety symptoms(Monitoring for adverse effects such as Exacerbation of anxiety symptoms done during follow up 10th, 20th and 30th day of treatment)
研究者
Dr Madhulika D Tiwari
Dr D Y Patil College of Ayurved and Research Centre