A Double Blind Placebo Controlled Clinical Study to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms such as occasional, mild emotional discouragement, mild stress, Frustration and the points mentioned in questionnaire.
研究概览
简要总结
This will be a double blind placebo controlledclinical study consisting of60subjects who fulfil the subjectselection criteria. According to the study, all the subjects will be advised to takeEmotional discouragement capsules or an identical looking placebo at adose of 1 capsule twice daily for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects with aged between 18-60 years.
- •2.Individual presenting with atleast one of the symptoms like occasional emotional discouragement, occasional /mild Stress/ irritability/ Short temper/Anger and Frustration.
- •3.Subjects willing to sign informed consent and follow the study procedure.
- •4.Has not participated in a similar investigation in the past four weeks.
排除标准
- •1.Those with serious cardiovascular, cerebrovascular, respiratory, liver or renal disease or any other disorder 2.The subjects who have used any drugs, for at least 1 week prior to the study 3.Subjects with a strong history of food or drug allergy of any kind 4.Individuals unwilling to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
1.Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms such as occasional, mild emotional discouragement, mild stress, Frustration and the points mentioned in questionnaire.
时间窗: Subjects will be followed up and the clinical assessment will be done on the following visit days: | Visit 0- At entry visit, baseline | Visit 1- At the end of 2nd week | Visit 2- At the end of 4th week | Visit 3- At the end of 6th week (End of the study).
2.Restoring levels of Blood levels of DHEA, Cortisol and CRP
时间窗: Subjects will be followed up and the clinical assessment will be done on the following visit days: | Visit 0- At entry visit, baseline | Visit 1- At the end of 2nd week | Visit 2- At the end of 4th week | Visit 3- At the end of 6th week (End of the study).
次要结局
- Compliance of the subject to the drug treatment and the incidence of events.(Subjects will be followed up and the clinical assessment will be done on the following visit days:)