to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement
- Conditions
- Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disordersHealth Condition 2: null- â?¢Individual presenting with atleast one of the symptoms like occasional emotional discouragement, occasional /mild Stress/ irritability/ Short temper/Anger and Frustration.
- Registration Number
- CTRI/2018/05/013614
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>2.Restoring levels of Blood levels of DHEA, Cortisol and CRP <br/ ><br>Timepoint: Subjects will be followed up and the clinical assessment will be done on the following visit days: <br/ ><br>Visit 0- At entry visit, baseline <br/ ><br>Visit 1- At the end of 2nd week <br/ ><br>Visit 2- At the end of 4th week <br/ ><br>Visit 3- At the end of 6th week (End of the study). <br/ ><br>
- Secondary Outcome Measures
Name Time Method Compliance of the subject to the drug treatment and the incidence of events.Timepoint: Subjects will be followed up and the clinical assessment will be done on the following visit days: <br/ ><br>Visit 0- At entry visit, baseline <br/ ><br>Visit 1- At the end of 2nd week <br/ ><br>Visit 2- At the end of 4th week <br/ ><br>Visit 3- At the end of 6th week (End of the study). <br/ ><br>