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临床试验/CTRI/2025/09/095119
CTRI/2025/09/095119尚未招募不适用

A randomized placebo-controlled clinical trial on the efficacy of a standardized homeopathic remedy Gelsemium sempervirens in the management of performance anxiety disorders among junior college student

Dr Shaina Bronika James1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年9月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Reduction in performance anxiety symptoms measured by Academic Anxiety Scale (AAS) scores.

研究概览

简要总结

This is a randomized, placebo-controlled clinical trial. The primary objective of the study is to determine whether the standard homoeopathic remedy Gelsemium Sempervirens provides reduction in performance anxiety symptoms as compared to a placebo. The study is being conducted at Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College and Hospital, including OPD, IPD, and various rural and urban camps conducted by the hospital. Participants will be screened using inclusion and exclusion criteria, and only those with a baseline Academic Anxiety Scale (AAS) score greater than 11 will be considered for the study. Comprehensive case taking will be performed for those whose academic anxiety scale score is greater than 11. Participants would be randomly assigned to either group A or group B with the help of a computer randomization technique. Group A  will be receiving Gelsemium Sempervirens. Group B will receive a placebo. Follow-up will be done every month, and assessment by using the academic anxiety rating scale will be done.

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
15.00 Year(s) 至 20.00 Year(s)(—)
性别
All

入选标准

  • Junior college students aged 15 to 20 years of both genders.
  • Academic Anxiety Scale (AAS) score greater than
  • Not receiving any other form of treatment for anxiety disorder.

排除标准

  • Students with severe psychiatric illnesses, including major depressive disorder, bipolar disorder, psychotic disorder and schizophrenia.
  • Currently using any psychiatric medication.

结局指标

主要结局

Reduction in performance anxiety symptoms measured by Academic Anxiety Scale (AAS) scores.

时间窗: Assessment will be done at baseline and at the end of 6 months using the Academic Anxiety Scale.

次要结局

  • Change in anxiety scores (Academic Anxiety Scale) comparison between intervention & placebo groups over the study period.(Assessment will be done at baseline & at the end of 6 months using the Academic Anxiety Scale.)

研究者

发起方
Dr Shaina Bronika James
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shaina Bronika James

Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Hospital

研究点 (1)

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