FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072643 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Behavioral 
Study Design  Other 
Public Title of Study   A comparative study between Modern Medicine and Ayurveda 
Scientific Title of Study   A Comparative Study between Escitalopram (Modern Medicine) and Jyotishmati (Ayurveda) in Depressive Disorder 
Trial Acronym  Treatment Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekram Goyal 
Designation  Assistant Professor 
Affiliation  Government Medical College, Patiala 
Address  Government Medical College and Rajindra Hospital, Department of Psychiatry, Room no. 5
Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001
Patiala
PUNJAB
147001
India 
Phone  7888657604  
Fax    
Email  ekram.goyal8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ekram Goyal 
Designation  Assistant Professor 
Affiliation  Government Medical College, Patiala 
Address  Government Medical College and Rajindra Hospital, Department of Psychiatry, Room no. 5
Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001

PUNJAB
147001
India 
Phone  7888657604  
Fax    
Email  ekram.goyal8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ekram Goyal 
Designation  Assistant Professor 
Affiliation  Government Medical College, Patiala 
Address  Government Medical College and Rajindra Hospital, Department of Psychiatry, Room no. 5
Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001

PUNJAB
147001
India 
Phone  7888657604  
Fax    
Email  ekram.goyal8@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Patiala 
 
Primary Sponsor  
Name  Government Medical College, Patiala 
Address  Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Government Ayurvedic College Patiala  Moti Bagh, Patiala, Punjab 147001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ekram Goyal  Government Medical College, Patiala  Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001
Patiala
PUNJAB 		 7888657604

ekram.goyal8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Guru Ravidas Ayurved University, Hoshiarpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Jyotishmati, Reference: Nighantu, Route: Oral, Dosage Form: Taila, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: warm milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient diagnosed with depressive disorder as per ICD 10 criteria 
 
ExclusionCriteria 
Details  Patients who refused to give consent
Patient with Intellectual Disability 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Jyotishmati and Modern Medicine in Depressive Disorder  Hospital based and follow up study with assessment at baseline and after 6 months.  
 
Secondary Outcome  
Outcome  TimePoints 
To document the onset, course, severity & clinical presentation of depression  Assessment will be done at baseline & after 6 months. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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/ Phase 3 
Date of First Enrollment (India)   22/08/2024 
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="1"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ekram.goyal8@gmail.com].

  6. For how long will this data be available start date provided 08-02-2023 and end date provided 07-02-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Depression is a common condition that often remains undiagnosed and untreated. Depression is a common mental disorder cutting across age, gender and socioeconomic status in India and across the world.

Depression is a state of low mood and aversion to activity or apathy that can affect a person’s thoughts, feelings, behavior and sense of well-being. It is a very serious and disabling psychiatric condition that occasionally leads to suicide or premature death due to unattended physical problems.

The criteria for diagnosing depressive episodes in ICD–10 and DSM–IV overlap considerably but have some differences of emphasis. In ICD–10 the patient must have two of the first three symptoms (depressed mood, loss of interest in everyday activities, reduction in energy) plus at least two of the remaining seven symptoms; while in DSM–IV the patient must have five or more out of nine symptoms with at least one from the first two (depressed mood and loss of interest). Both diagnostic systems require symptoms to have been present for at least 2 weeks to make a diagnosis (but can be shorter in ICD–10 if symptoms are unusually severe or of rapid onset). In both ICD–10 and DSM–IV the symptoms must result in impairment of functioning that increases with the episode severity.

Aim :

1.     To assess the efficacy of Ayurveda (Jyotishmati) in depressive disorder and its comparison with Modern Medicine (Escitalopram).


 
Close