跳至主要内容
临床试验/CTRI/2019/08/020756
CTRI/2019/08/020756已完成2/3 期

"Exploring the role of Lasunadya Ghrita Pana & Nasya in case of Primary Depression:A non randomized open clinical study".

Self1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年4月16日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Improvement in Hamilton Depression Scale

研究概览

简要总结

Mental health is given foremost importance in ayurveda.Depression as a disease has many peculiarties.It may begin early at the age,may have multifaceted causes of which many may belong to the life style stressors,may results in huge personal, interpersonal, social and economical losses and may end up in suicidal attempts.It is in this purview,we are proposing to sceen Lasunadya ghrita for its therapeutic potential in cases of primary depression.Lasunadya ghrita is identified as a potential drug to unmad, a mental condition refered in ayurveda and having some resemblance to depression in context to it’s kaphaj subtype. Lasunadya ghrita is recommended to be used in such cases as an oral medication as well as in the form  of instillation.For the purpose of present study we propose to have an enhanced effect on depression.The study is proposed to be non randomized open clinical trial having comparison of ayurvedic protocol with that of current psychiatric protocol.This clinical trial consisting of two groups namely interventional group and active comparator group.Intervention group is proposed to be given lasunadya ghrita nasya for 20 sitting comprising of approximately 5 sitting in a week.In addition to nasya this group is also recommended for lasunadya ghrita pana in a dose of 5 gram in a day in two divided with warm milk before meal for 4 weeks.Active comparator group is proposed to be given conventional pharmacotherapy for depression (Escitalopram 10 mg HS) as recommended by department of psychiatry kgmu Lucknow.In the study the total sample is considered to be 72 with approximate 36 sample in each group.For outcome assessment a significant reduction in HAMD score (less than 7) will be considered as remission to an individual patient.

研究设计

研究类型
Interventional
分配方式
Not Applicable
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

  • Patient diagnosed as primary depression as per ICD-10 criteria.patient having depression for not more than two years.patients willing to participate in the study voluntarily giving their informed consent.patient not having any other physical and mental co-morbidity considered as contraindication to the treatment.

排除标准

  • Patient below 20 years and over 60 years.Patients having any other psychiatric co-morbidity.Patient having cognitive malfunctions due to substance abuse or due to age related dementia or mental retardation.Females in the stage of pregnancy or lactation.Patients having suicidal ideation or history of attempted suicide.Patients with marked irritable,unstable and violent behaviour.Patients allergic to any component of medication.Patients unable to take lasun or go-mutra due to their personal customs or belief.Patients not giving the consent for the study.Any condition where nasya is contraindicated.

结局指标

主要结局

Improvement in Hamilton Depression Scale

时间窗: Base line and 4 week

次要结局

  • SF-36(Base line and Week 4)

研究者

发起方
Self
申办方类型
Other [individual]

研究点 (1)

Loading locations...

相似试验

Exploring the role of Lasunadaya Ghrita pana and... | 临床试验