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临床试验/CTRI/2022/11/047682
CTRI/2022/11/047682已完成2 期

Efficacy Of Jatamansi Arka And Sarpagandhaghana Vati In Major Depressive Disorder - A Randomized Controlled Trial

Dr Kavya Shree S1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月3日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Primary outcome of MDD on the basis of MADRS in 60 Days

研究概览

简要总结

According to  WHO’s the definition of health goes like this : Health is a state of complete physical, mental and social well being and not merely the absence of disease. And when mainly emphasizing on , Mental health refers to behavioral, cognitive and emotional well being. any changes in this well being can be considered as mental disorder ,which includes most commonly mood disorder, GAD, personality disorder, sleep disorders. Mental health is an integral part of our general health and well being and a basic human rights.

Depression being a very common disease is a major cause of suicidal death and disability. It commonly presents with symptoms like fatigue, worthlessness, guilt, loss of interest in daily activities,  afflicting the person’s mental, physical and social life. It is estimated that 3.8% of world population is afflicted with depression out of which 5.0% are among adults and 5.7% are among the adults more than 60yrs. In India 45.7 million people are suffering from this disorder out of  which 3.9% is contributed by female population and 2.7% by male population. People exposed to unfavourable circumstances like poverty, violence and inequality are at high risk of experiencing mental health conditions  which are also reported to be a risk factor for several secondary disorders. These people are prone to have recurrence of depression episodes. Conventional practice of oral medicines include SSRI & Anti-depressant group of drugs which are having adverse effects varying from simple dry mouth to many cardiovascular risks .

Similarly in the context of ayurveda, manas is made of  3 doshas i,e satva, rajas and tamas and alteration of these mano doshas causes manovikaras like atatvabinivesha, unmada, apasmara vyadhis, avasaada, vishada chittodwega - which are nothing but abnormal condition related to mental function.

In Ayurveda the above said condition can be correlated  with Kaphaja unmada [Mano vikara] .Classically Jatamansi arka and Sarpagandhaghana vati are being used to treat manovikaras. Having this idea as a whole, plan for further study is made for the better outcome in patients health.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • 1.Individuals between the age group of 20 to 60 years 2.Patients of Either sex 3.Subjects fulfilling the diagnostic criteria DSM 5.

排除标准

  • 1.Patients with Axis II disorder like personality disorders ​ 2.Patients with other Axis I disorders like schizophrenia psychosis Anxiety disorders etc 3.Evidence of active suicidal ideation​ 4.Depression with Psychotic symptoms​ 5.Use of Psychotropics therapy drugs within the past period of 4 weeks​ 6.Pregnant or lactating women​ 7.Any other Chronic illness like Diabetes mellitus Cardiovascular diseases.

结局指标

主要结局

Primary outcome of MDD on the basis of MADRS in 60 Days

时间窗: Base line 15days 30days 45days 60days

次要结局

  • Secondary Outcome of MDD on the basis of CGI-Clinical Global Impression-Severity Index Global Improvement Efficacy Index, BHS-Becks Hopelessness Scale, WHO QOL BREF-World Health Organization Quality Of Life Bref, PSQI-Pittsberg Sleep Quality Index, UKU- UKU Side Effect Rating Scale, HAM-A-Hamilton Anxiety rating Scale in 60days(Baseline, 15days, 30days, 45days, 60days)

研究者

发起方
Dr Kavya Shree S
申办方类型
Other [Self sponsored PG dissertation work]

研究点 (1)

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