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临床试验/CTRI/2019/05/019140
CTRI/2019/05/019140尚未招募2/3 期

A Clinical Study to assess the combined effect of Shirodhara, Kalyanaka Ghritha and Satvavajaya Chikitsa in reducing the symptoms of Social Anxiety Disorder

Amrita School of Ayurveda1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
DSM 5 Assessment Criteria

研究概览

简要总结

Background: Social Anxiety disorder [SAD] is a prevalent anxiety disorder characterized by significant amount of fear in one or more social situations which is persistent, typically lasting for 6 months or more. According to DSM 5, its prevalent rate decreases with age, more in adolescents than in young adults. In general, higher rates of social anxiety disorder is found in females than in males in the general population. The 12 month prevalence for older adults ranges from 2% to 5%. The present day management of Social Anxiety Disorder involves usage of anxiolytics and their use is limited owing to the risk of drug abuse and dependence.

Ayurveda is a science of life and gives equal significance to physical, mental, social and spiritual health. In the life time, one may suffer from physical, mental and spiritual ailments of which the Acharya’s have elaborately mentioned in classical texts (Samhitas). Based on the symptoms of SAD, there are similar references in Bhagavat Gita and Visadhata lakshana from Ashtangahrdaya. It refers to the Udvega Avastha of Manas (excited state of mind) which is caused by vitiated Rajas and having the predominance of Vata and Pitta Dosha.

Shirodhara is considered the best therapy for diseases pertaining to the head, eye and ear, gives good sleep and which helps in relieving stress and Vata Vrddhi symptoms and that of Social Anxiety Disorder. Kalyanaka Ghritha mentioned in Charaka Samhitha, Unmada Chikitsa, is having Medhya property so it is selected as the Samanoushada for Social Anxiety Disorder. Satvavajaya Chikitsa provides Dhi, Dhairya, Atma jnana and Asvasana to the patient. This study aims to explore safe, effective and economical management of SAD following the therapeutic principles of Ayurveda.

Objective:  To find out the combined effect of Shirodhara, Kalyanaka ghritha and Satvavajaya Chikitsa in reducing the symptoms of Social Anxiety Disorder using DSM-5 Assessment Scale.

Study Design: It will be a single group clinical study with pre and post-test study Design. 20 Patients who fulfil the inclusion criteria will be taken. Patient will be evaluated according to Diagnostic and Statistical Manual of Mental Disorders Assessment Criteria and the following treatment will be given.

**Method:**Pacana Deepana will be administered on OP basis with Vaishwanara Choorna (12gm) in a divided dosage with hot water and Gandharvahastadi Kashaya (48 ml dosage) with a pinch of saindhava (Rock salt) and jaggery before food twice daily for 1-7 days. Then patient will be admitted to the ward and Shirodhara will be administered with Balaguduchyadi Taila (8th- 14th day). Simultaneously Satvavajaya chikitsa (8th -14th day) and Kalyanaka Ghritha (48 ml) in a divided dosage before food as Samanoushada for (8th -30th day).

研究设计

研究类型
Interventional

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the diagnostic criteria for Social Anxiety Disorder as per DSM 5 Diagnostic criteria.
  • Age between 20 to 60 years.
  • Patients with either gender irrespective of socioeconomic status Patients willing to join the study and sign the informed consent form.

排除标准

  • Patients with other psychiatric disorders Pregnant women, Lactating mothers and children.
  • Patients with metabolic disorders and other systemic disorders.

结局指标

主要结局

DSM 5 Assessment Criteria

时间窗: 30 days

次要结局

  • DSM 5 Assessment Criteria(30 days)

研究者

发起方
Amrita School of Ayurveda
申办方类型
Private medical college

研究点 (1)

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