A Prospective, Randomised, Comparative clinical study to Evaluate the Efficacy and Safety of Ayurvedic Medicine Medha Vati & Allopathic Medicine Sertraline in the Management of Depression.

National Institute of Medical Sciences Research Jaipur1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2020年6月22日最近更新: 2020年8月6日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 120
试验地点: 1
主要终点: Reduction In Depressive Symptoms In HAM-D Score

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This Study is a Randomised Interventional trial to compare the Safety and Efficacy of Ayurvedic Medicine Medha Vati and Allopathic Medicine Sertraline in patients of Depression as per inclusion and exclusion criteria of the study.

The study will be conducted at Psychiatry OPD of NIMSR, JAIPUR . The primary outcome measure will be reduction of Depressive score in HAM-D scale in 4 weeks and secondary outcome will be Satisfactory Reduction in HAM-D score in 12 weeks.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Not Applicable

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 newly diagnosed as Depression of age 20-60 years as per icd-10 criteria with written informed consent by the patients.
•The HAM-D will be used to assess the severity of Depression.

排除标准

•1 Age less than 20 years and more than 60 years 2 Pregnant and lactating women 3 Major medical chronic disorders 4 Severe depression with psychotic features or suicidal risks 5 Patient who do not give consent for the study.

结局指标

主要结局

Reduction In Depressive Symptoms In HAM-D Score

时间窗: 1 Month

次要结局

Satisfactory Improvement In Depressive Symptoms In HAM-D Score(3 Months)

研究者

发起方

National Institute of Medical Sciences Research Jaipur

申办方类型

Private medical college

研究点 (1)

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