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临床试验/CTRI/2024/09/073245
CTRI/2024/09/073245尚未招募3 期

Evaluation of Extra pharmacopeial herb Bhangjeera (Perilla frutescens Linn.) seed in the management of Generalized Anxiety Disorder (GAD) in adults: An Exploratory Clinical Study

Dr Vanshika Sharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the anxiolytic effect of extrapharmacopoeial herb : Bhangjeera (Perilla frutesecens Linn)

研究概览

简要总结

Anxiety disorders (ADs) are among the most common psychiatric illnesses that impact the quality of life, functioning and productivity of an individual. As per the World Mental Health Survey (WMHS), the lifetime prevalence of Anxiety disorders across different countries ranges between 3% and 19%. According to NMHS 2016, prevalence of ADs was 2.57%.Though, the prevalence of anxiety disorder is less but the overall quality of life of these patients is poor. The conventional treatment of this condition indicates the use of sedatives, hypnotics and antidepressant drugs along with the cognitive behavioral therapy. Still, the prognosis for patients with generalized anxiety disorder is guarded. Many patients are not compliant with medications because of cost and adverse effects. Relapses are common, and patients often search for physicians who comply with their needs. Because of the lack of conventional medicine to cure the disorder and their considerable side effects, many opt for alternative therapies.The herb Bhangjeera (Perilla frutescens Linn) has traditionally been used to treat depression-related disease, and is reported as potent anxiolytic. Japan has reported its clinical potential in Age related Cognitive Decline (ARCD).  Reviews reflect that oral administration of seed is not reported in any clinical studies. Due to unfavorable palatability of seeds in their original form, it is difficult to administer the seeds for therapeutic purposes for longer duration. To explore its utilization, efforts are needed for development of better consumable forms / food products, so that they can be incorporated in the diets of common man. Further the developed consumable forms can also be used to ensure better patient compliance and evaluation of herb for its pharmacological potential.

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 45.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the diagnostic criteria of GAD as per DSM V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) guidelines.
  • Hamilton anxiety score
  • Age 18 to 45 years, irrespective to gender, caste, socio-economic status.

排除标准

  • Patient suffering from known case of psychiatric disorder other than GAD.
  • Patient with known history of Thyroid dysfunction or any major systemic diseases requiring significant care.
  • Patient suffering from GAD and taking other medications.
  • Patient with substance, alcohol, Smoker’s dependence.
  • Pregnant women and lactating mothers.

结局指标

主要结局

To evaluate the anxiolytic effect of extrapharmacopoeial herb : Bhangjeera (Perilla frutesecens Linn)

时间窗: At the end of the intervention period i.e 60 days

次要结局

  • Development of laddu/modaka of Bhangjeera (Perilla frutescens)(Baseline)

研究者

发起方
Dr Vanshika Sharma
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vanshika Sharma

All India Institue of Ayurveda, New Delhi

研究点 (1)

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