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临床试验/CTRI/2025/01/079152
CTRI/2025/01/079152尚未招募3 期

Clinical study on Psychopharmacological therapeutic efficacy of Vidarikand (Pueraria tuberosa Roxb. ex Willd) in the Management of Chittodwega (Generalized Anxiety Disorder) - An Open Randomized Controlled Clinical trial

D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2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
Reduction in Anxiety symptoms, as measured by HAM-A, DASS 21, AAA Scale over the course of intervention

研究概览

简要总结

Chittodwega is a psychological disorder which can be defined as an ’anxious state of mind.’ Generalized Anxiety disorder’ is an anxiety disorder characterized by anxiety and worry that is not associated with a particular object, situation or event but seems to be a constant feature of a person’s day to day life, along with physical

symptoms of stress lasting a period of 6 months.

Impact of GAD on quality of life : Excessive concern, restlessness, difficulty sleeping, tiredness, irritability, sweating, trembling etc. interfere with work, relationships and other parts of life, suicidal thoughts, if untreated may lead to major psychological disorders (psychosis, schizophrenia)

GAD is under detected due to fear and shyness. It has high prevalence rates, poor quality of life, difficulties in detection, treatment, tendency to be chronic and associated with comorbidities. Even then it remains least studied.

Treatment gap : 70-80 %

Problems in conventional treatments : SSRIs have various side effects ( Nausea, Drowsiness, Insomnia, habit forming, sedating, sexual problems, agitation etc.)

Need for safer treatment : All these limitations are encouraging the patients to explore for possible therapies in complementary and alternative systems of medicine. Ayurveda is a great treasure of precious concepts like Rasayana (Rejuvenation therapy) which can be very well utilized to combat with this burning issue.

In Sushrut Apasmar Chikitsa, use of Vidaryadi gana and Kakolyadi gana have been mentioned which is a direct reference for use of Vidarikand (Su.Uttarsthana.61.29) for our present study of Manas vikar. Besides, Puerarin an active constituent of vidari has already been proven as an anxiolytic, neurotonic. With present study we hope to explore the role of Vidarikand in Chittodwega.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 39.00 Year(s)(—)
性别
All

入选标准

  • Patients having cardinal symptoms of GAD for more than 6 months.

排除标准

  • Patients below 18 and above 39 years Patients with other ADs like OCD, BPD, phobias etc.
  • Pregnant and lactating women Immunocompromised patients Patients with Substance abuse disorders.

结局指标

主要结局

Reduction in Anxiety symptoms, as measured by HAM-A, DASS 21, AAA Scale over the course of intervention

时间窗: 60 days

次要结局

  • Reduction in Anxiety and its symptoms(60 days)

研究者

发起方
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anushka Motwani

D.Y. Patil School of Ayurveda

研究点 (1)

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