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临床试验/CTRI/2024/08/073067
CTRI/2024/08/073067已完成1/2 期

Effectiveness of an Integrated Treatment Protocol in the Management of Chittodvega w.s.r. to Generalised Anxiety Disorder

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Hamilton Anxiety Rating Scale

研究概览

简要总结

The term Chittodvega correlated with the symptomatological explanation of Generalised Anxiety Disorder (GAD). The global prevalence of anxiety disorders in 2019 was 4.05%.Medications that widely use in anxiety have been found with considerable amount of adverse drug events. Both psychotherapy and pharmacotherapy have been shown to be more effective in previous research studies. Therefore, the study is planned with a combination of Sarvanga abhyanga with Ksheerabala oil, Sarvanga Parisheka with Dashamula Kwatha, Thakradhara, Ashwagandha and Yashtimadhu churna with milk, Shiva panchakshari mantra japa listening, Buddhist meditation and Psychotherapy for a period of five days. All the interventions planned in the study have already depicted positive impact separately in the management of Chittodvega w.s.r to GAD and current study expects to observe the combined effect of the selected protocol. Main objective of this study is to evaluate the effectiveness of integrated treatment modality in Chittodvega W.S.R. to Generalised Anxiety Disorder. The study will be an open labeled single arm clinical trial in the inpatient department at Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan. Data will be collected using specially prepared case report forms, irrespective of caste, sex and religion. Sample size is 35. Participants will be diagnosed on the basis of 6B00 Generalised Anxiety Disorder ICD-11.  Participants who are willing to give informed consent and comply with study procedures irrespective of gender and socio-economic status and between 18-60 years of age will be included and pregnant and lactating females, individuals with comorbid psychiatric disorders and those who are unable to undergo with the selected treatment protocol will be excluded. Hamilton Anxiety Rating Scale and Galvanic Skin Response will be used for the assessment at 0th day before treatment, 03rd day at treatment and 06th day after the treatment. The data will be analyzed using an appropriate statistical software.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Participants irrespective of gender Participants between 18 and 60 years of age irrespective of socio-economic status Participants willing to give informed consent and comply with study procedures.

排除标准

  • Pregnant and lactating female Participants suffering from comorbid psychiatric disorders The individuals those who are unable to undergo with the selected treatment protocol.

结局指标

主要结局

Hamilton Anxiety Rating Scale

时间窗: Hamilton Anxiety Rating Scale will be Used to Assess the cases before treatment 0th day and at the end of treatment 5th day

次要结局

  • Galvanic Skin Response(At before treatment in day 0 & at the end of treatment day 5)

研究者

发起方
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ruwan Priyantha Liyanage

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

研究点 (1)

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