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

A Double Blind Placebo Controlled Clinical Study to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement - EmoDc

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013614
Enrollment
60
Registered
2018-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders Health 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.

Interventions

Intervention1: Emotional discouragement capsules: Emotional discouragement, Each capsule contains Ashvagandha (Withania somnifera root), Brahmi (Bacopa monierii), Shankhapushpi (Convolvulus pluricauli

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. 2.Restoring levels of Blood levels of DHEA, Cortisol and CRP Timepoint: 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

MeasureTime frame
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: 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).

Countries

India

Contacts

Public ContactDr Palaniyamma

The Himalaya Drug Company

dr.palani@himalayawellness.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026