跳至主要内容
临床试验/CTRI/2024/06/069165
CTRI/2024/06/069165尚未招募不适用

To evaluate the effect of constitutional homoeopathic treatment in Social Anxiety Disorder–A Prospective Open Label Interventional Study

The Calcutta Homoeopathic Medical College & Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月30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
60
试验地点
1
主要终点
Social Anxiety Disorder Severity Scale

研究概览

简要总结

Social anxiety disorder; ICD11:6B04;(also referred to as social phobia) involves the fear of social situations, including situations that involve scrutiny or contact with strangers. They are fearful of embarrassing themselves in social situations (i.e., social gatherings, oral presentations, meeting new people).It is the third most common psychiatric condition after major depression and alcohol dependence. Educational achievement can be undermined, with a heightened risk of leaving school early and resulting in poor academic performance and qualifications.Left untreated, social anxiety disorder is recognized as a debilitating and highly prevalent disorder that may result in lower educational attainment, worse occupational performance, hampered social interaction, lower-quality relationships, and decreased quality of life. SAD is associated with suicidal ideation, low self-esteem, lower socioeconomic status, unemployment, financial issues, and being unmarried. There is a lot of scope in the practice of homeopathy in mental diseases. Due to unavailability of studies in homoeopathy in this field, studies need to be conducted. Prospective Open Label Interventional Study will be conducted on Outpatients of Calcutta Homoeopathic Medical College, Kolkata, for 18months.Due to lack of literature on this subject and time constraints,60 was taken as sample size. Assessment done by two scales Social Anxiety Disorder Severity Scale (SAD-D) and 36-Item Short Form Health Survey questionnaire (SF-36). Results will be published in scientific journals.

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 65.00 Year(s)(—)
性别
All

入选标准

  • • Inclusion criteria: 1 Aged between 18-65years 2 Patients fulfilling the diagnostic criteria for Social Anxiety Disorder as per DSM
  • 3 Patients willing to join the study and sign the informed consent form.
  • 4 Patients with either gender,including transgender 5 Literate patients able to read and write English ,Bengali or Hindi.
  • 6 No history of medications since last 6 months period, prior to entry into the study.

排除标准

  • 1 Patients with other psychiatric disorder.
  • 2 Pregnant women, Lactating mothers and children.
  • 3 Patients with metabolic disorders and other systemic disorders 4 Current psychoactive substance dependence or substance abuse.
  • 5 Previous psychological therapy in the last 1 year.
  • 6 Head injury or other neurological disorder.
  • 7 H/o suicidal or self harming tendency.
  • 9 Simultaneous participation of any other clinical trials.

结局指标

主要结局

Social Anxiety Disorder Severity Scale

时间窗: At the end of every 2 months upto 6months,with follow up every 15 days

次要结局

  • The 36-Item Short Form Health Survey questionnaire (SF-36)(At the end of every 2 months upto 6months,with follow up every 15 days)

研究者

发起方
The Calcutta Homoeopathic Medical College & Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shreyasi Sengupta

The Calcutta Homoeopathic Medical College and Hospital

研究点 (1)

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