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临床试验/CTRI/2025/03/082599
CTRI/2025/03/082599尚未招募4 期

Comparative study of Vamana Karma and Shirovirechana Nasya followed by Shamana Snehapana and Satwavajaya Chikitsa with Yoga in managing major depressive disorder- An Open Labelled Randomised Controlled Clinical Trial.

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
72
试验地点
1
主要终点
1.Reduction in hamilton depression rating Score.

研究概览

简要总结

Major depressive disorder is a common and debilitating mental illness that is characterized by a depressed mood, appetite change, sleep disturbance, mental retardation or agitation, fatigue, guilt, loss of concentration, and suicidal ideation. Its worldwide prevalence is estimated at 4.4%.In India, it is estimated that nearly one-third of patients seeking help from healthcare facilities could have symptoms related to depression, and the crude prevalence rate of mood disorder was estimated to vary from as low as 0.5 to as high as 78 per 1000 population. Therefore in this study, Vamana Karma, Shirovirechana Nasya, Shamana Snehapana and Satwavajaya Chikitsa with Yoga is selected as the line of protocol for treating major depressive disorder. Vamana Karma can be done with Dhamargava Phala Churna. Dhamargava is indicated as the best medicine for Vamana in psychiatric disorder. For Shirovirechana Nasya, Jyotishmati Taila will be used as it is indicated as Medhya and is also included in Shirovirechana AushadhiKalyanaka Ghrita will also be used for Shadhananga Snehapana, Snehana Nasya and also for Shamana Snehapana. No previous study is available to evaluate the effect of the Panchakarma procedure on the neurofilament light chain. Hence this study is conducted to prepare an effective Ayurveda protocol to treat major depressive disorder and to show the effect on the neurofilament light chain.

Null Hypothesis-H****0- There is no difference between Vamana Karma and Shirovirechana Nasya followed by Shamana Snehapana and Satwavajaya Chikitsa with Yoga on hamilton depression rating scale in patients of major depressive disorder when measured with neurodegeneration biomarker neurofilament light chain.

Alternate Hypothesis-H****1 –There is a difference between Vamana Karma and Shirovirechana Nasya followed by Shamana Snehapana and Satwavajaya Chikitsa with Yoga on hamilton depression rating scale in patients of  major depressive disorder when measured with neurodegeneration biomarker neurofilament light chain.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with DSM-5 criteria for major depressive disorder.
  • Patients Yogya for Virechana, Nasya and Shamana Snehapana.
  • Patients irrespective of their sex, caste, or religion.

排除标准

  • 未提供

结局指标

主要结局

1.Reduction in hamilton depression rating Score.

时间窗: At baseline, 23rd day and on 45th day

次要结局

  • 1.Improvement in WHOQOL-BREF scale(2.Change in neurodegenerative biomarker level of serum neurofilament light chain.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Akash Sharma

All India Institute of Ayurveda

研究点 (1)

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