to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement

Phase 2

Recruiting

• Conditions: Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, •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

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-04
• Last Update Posted: 2019-02-14

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

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.	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	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).

Secondary Outcome Measures

Name	Time	Method
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:

Trial Locations

Locations (1)

L N Ayurved College & Hospital; 🇮🇳 Bhopal, MADHYA PRADESH, India

L N Ayurved College & Hospital

🇮🇳Bhopal, MADHYA PRADESH, India

Prof Dr Sadhana Waikar

Principal investigator

09975215548

drswaikar@gmail.com