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临床试验/CTRI/2024/07/070647
CTRI/2024/07/070647已完成3 期

Effect of an Ayurvedic treatment protocol in the management of Late life depression-A Pre Post Test Study

Dr Sandeep S1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Change in depression scores as of Geriatric Depression Scale

研究概览

简要总结

Late life depression is one among the serious health concerns that are associated with comorbidity, impaired functioning, excessive use of health care resources and increased mortalities including suicides. In ayurveda sufficient research has not happened in this area. Based on various ayurvedic texts, this condition can be compared with Kaphaja Unmada. So here the treatment protocol comprises of administration of Brahmi ghrita after pachana dipana with Ashta churna for balance of tridoshas predominantly Vatha and kapha. Satvavajaya chikitsa  which is considered as the main modality for mental and emotional distress by restraining mind from unwholesome objects is also integrated to the protocol. GDS 15 is the commonly used instrument for the screening of Late life depression with higher diagnostic accuracy. Hence the before and after changes of the score in 36 patients will be statistically analysed for a trial duration of 16 months.

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
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • GDS Score range 5-
  • Those who are willing to participate in this study and sign informed consent forms.
  • Patients with 5 or more of the 9 symptoms of major depressive disorder mentioned in DSM-5,persisting for a period of 2 weeks.

排除标准

  • Abnormal cognition and speech-causing difficulty in comprehension,expression and signing informed consent.
  • Previously diagnosed neurological and psychiatric diseases Previously diagnosed with chronic infection Individuals on medication having fasting Plasma glucose level above 126 mg/dl and post prandial 160 mg/dl.
  • Individuals on medication having Blood pressure above 150/90 mm hg.
  • Individuals on medication having Total Cholesterols level above 190mg/dl.

结局指标

主要结局

Change in depression scores as of Geriatric Depression Scale

时间窗: 98 days

次要结局

  • Quality of analysis based on PHQ-9 questionnaire

研究者

发起方
Dr Sandeep S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sandeep S

Amrita School of Ayurveda

研究点 (1)

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