Pharmacoinformatics and Clinical Insights: Unraveling the Therapeutic Potential of Mundi (Sphaeranthus indicus Linn) in Generalized Anxiety Disorder through In-silico Analysis and Randomized Open-Labelled Comparative Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HARS LESS THAN 17
研究概览
简要总结
Generalized Anxiety Disorder (GAD) presents a significant burden on individuals and society, necessitating the exploration of effective treatments. Sphaeranthus indicus Linn, known as the "East Indian Globe Thistle," has gained attention due to its traditional use in alleviating anxiety. In Ayurveda, it’s recognized for its mental health benefits and categorized as a "Medhya Rasayana," indicating its potential to reduce anxiety and enhance cognitive function. Various dosage forms of Sphaeranthus indicus L. are employed in Ayurvedic practice, highlighting its versatility and efficacy in addressing diverse health concerns.Phytochemical analysis reveals compounds like flavonoids, alkaloids, and polyphenols in Sphaeranthus indicus L., which may act synergistically to modulate neurotransmitter systems and oxidative stress pathways, potentially alleviating anxiety. Molecular docking and dynamics simulations will investigate these interactions with key anxiety-related targets like GABA and serotonin receptors, providing insights into their anxiolytic mechanisms.To validate in-silico findings, clinical studies involving GAD-diagnosed participants will assess Sphaeranthus indicus L.’s safety and efficacy compared to placebos or standard anxiolytic medications. Objective measures such as anxiety scales and physiological parameters will gauge treatment outcomes.This multidisciplinary approach integrates traditional herbal wisdom with modern scientific methodologies, aiming to provide alternative treatments for GAD. If proven effective, Sphaeranthus indicus L. could offer a natural and safer alternative to synthetic drugs, potentially improving the quality of life for GAD sufferers. By synthesizing in-silico predictions with clinical assessments, this research seeks to comprehensively evaluate the therapeutic potential of Sphaeranthus indicus L., opening new avenues for GAD management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients fulfilling the criteria of Generalized Anxiety Disorder as per DSM V guidelines.
- •Hamilton anxiety score more than
- •Age 20 to 40 years, irrespective to gender, caste, socio-economic status etc.
排除标准
- •Patient suffering from any psychiatric disorder other than GAD.
- •Patient suffering from any major systemic disease requiring significant care.
- •Pregnant women and lactating mothers.
- •Patient not willing to participate in study.
结局指标
主要结局
HARS LESS THAN 17
时间窗: HARS LESS THAN 17
次要结局
- IMPROVEMENT IN GAD 7 SCALE(AFTER 2 MONTHS)
研究者
SUMEDH JOSHI
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
