跳至主要内容
临床试验/CTRI/2024/03/064361
CTRI/2024/03/064361招募中3 期

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

ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月1日最近更新:

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

发起方
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SUMEDH JOSHI

ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI

研究点 (1)

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