| CTRI Number |
CTRI/2018/05/013614 [Registered on: 02/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement |
|
Scientific Title of Study
|
A Double Blind Placebo Controlled Clinical Study to Evaluate Efficacy and Safety of Emotional discouragement capsules in Individuals presenting with mild occasional emotional discouragement |
| Trial Acronym |
EmoDc |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/028/2018 Ver 1.0 Date 13.02.2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Sadhana Waikar |
| Designation |
Professor |
| Affiliation |
L N Ayurved College & Hospital |
| Address |
LNCT University Kolar Road,
Bhopal, M.P.
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bhopal
KARNATAKA
462042
India |
| Phone |
|
| Fax |
|
| Email |
drswaikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company, Makali, Tumkur Raod, Bangalore |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company, Makali, Tumkur Raod, Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Sadhana Waikar |
L N Ayurved College & Hospital |
LNCT University Kolar Road,
Bhopal, M.P.
Bhopal
MADHYA PRADESH |
09975215548
drswaikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L N Ayurved College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||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., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emotional discouragement capsules |
Emotional discouragement, Each capsule contains Ashvagandha (Withania somnifera root), Brahmi (Bacopa monierii), Shankhapushpi (Convolvulus pluricaulis), Tulasi (Ocimum sanctum), Amalaki (Emblica officinalis).
This will be a double blind placebo controlled clinical study consisting of 60 subjects who fulfil the subject selection criteria. According to the study, all the subjects will be advised to take Emotional discouragement capsules or an identical looking placebo at a dose of 1 capsule twice daily for 6 weeks. |
| Comparator Agent |
Placebo |
identical looking placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
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
|
| Outcome |
TimePoints |
| 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:
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).
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a double blind placebo controlled
clinical study consisting of 60
subjects who fulfil the subject
selection criteria. According to the study, all the subjects will be advised to take
Emotional discouragement capsules or an identical looking placebo at a
dose of 1 capsule twice daily for 6 weeks. |