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CTRI Number  CTRI/2025/02/081020 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Investigating the Link Between Digestive Fire (Jatharagni) and Depression: An Ayurvedic Perspective 
Scientific Title of Study   Evaluation of the status of Jatharagni in newly diagnosed Patients of Depression 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Barad Vatsal Harajbhai 
Designation  MD Scholar 
Affiliation  J.S.Ayurveda Mahavidhyalaya 
Address  Department Of Kriyasharir, J.S.Ayurveda Mahavidhyalaya, Collage Road , Nadiad, 387001

Kheda
GUJARAT
387001
India 
Phone  9978353824  
Fax    
Email  baradvatsal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrProfPoorvi K Vyas 
Designation  Professor 
Affiliation  J.S.Ayurveda Mahavidhyalaya 
Address  Department Of Kriyasharir, J.S.Ayurveda Mahavidhyalaya, Collage Road , Nadiad, 387001

Kheda
GUJARAT
387001
India 
Phone  9979326852  
Fax    
Email  vdpoorvik31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Barad Vatsal Harajbhai 
Designation  MD Scholar 
Affiliation  J.S.Ayurveda Mahavidhyalaya 
Address  Department Of Kriyasharir, J.S.Ayurveda Mahavidhyalaya, Collage Road , Nadiad, 387001

Kheda
GUJARAT
387001
India 
Phone  9978353824  
Fax    
Email  baradvatsal@gmail.com  
 
Source of Monetary or Material Support  
P D Patel Ayurveda Hospital; J S Ayurveda Mahavidhyalaya College road Naidad 387001 Gujarat India 
 
Primary Sponsor  
Name  JSAyurveda Mahavidhyalaya 
Address  J.S.Ayurveda Mahavidhyalaya, College Road, Nadiad 387001 Gujarat India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRVatsal Harajbhai Barad  J.S.Ayurveda Mahavidhyalaya  P.G.Tutorial Room,No.101, Department Of Kriyasharir, J.S.Ayurveda Mahavidhyalaya,College Road, Nadiad,387001
Kheda
GUJARAT 		 9978353824

baradvatsal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAGANBHAI ADENWALA MAHAGUJRAT UNIVERSITY Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F322||Major depressive disorder, singleepisode, severe without psychotic features. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Participants newly diagnosed with depression based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. The diagnosis must be confirmed by a licensed psychiatrist, and the participants must have been diagnosed within the last seven days.
Cognitive Ability: Participants must demonstrate sufficient cognitive ability to understand and respond to study questions. This will be assessed using the Clock Drawing Test, a brief cognitive screening tool, before inclusion.
Willingness to Participate: Participants must provide informed consent and agree to complete all study procedures and assessments.
Healthy Controls (for Control Group):
Adults between the ages of eighteen and thirty-five years with no history of psychiatric disorders.
Participants must meet the criteria for good health status as determined by the Swasthya Assessment Scale of CCRAS.
Inclusivity: Participants will be included irrespective of their gender, socioeconomic status, or educational background. 
 
ExclusionCriteria 
Details  • Severe Psychiatric Disorders: Individuals with severe psychiatric disorders such as schizophrenia or bipolar disorder.
• Substance Abuse: Individuals with a history of substance abuse or dependence.
• Neurological Disorders: Individuals with diagnosed neurological conditions (e.g., Parkinson’s disease, multiple sclerosis, epilepsy) that could directly affect cognitive function.
• Chronic Illnesses: Individuals with chronic medical conditions (e.g., hypertension, diabetes, heart disease) that may indirectly influence cognitive function over time.
• Pregnancy and Lactation: Female participants who are currently pregnant or in the lactating period.
• Interfering Medications: Individuals currently taking medications known to interfere with depression treatment (e.g., certain antidepressants, and antipsychotics).
• Non-compliance: Individuals who do not have the ability or willingness to comply with study requirements, including attending appointments and following treatment protocols.
• Cognitive Impairment: Individuals demonstrating significant cognitive impairment as determined by the Clock Drawing Test, indicating they may be unable to reliably participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to evaluate the correlation between the status of Jatharagni and depression.  54 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Jatharagni status between newly diagnosed depression patients and healthy controls.
To assess the overall health status of healthy controls using the Swasthya Assessment Scale of CCRAS. 		 54 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   25/02/2025 
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="0"
Days="0" 
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 - NO
Brief Summary  

HYPOTHESIS 

Null hypothesis (H0)

There is no statistically significant relationship between Agni and newly diagnosed depression in the study population.

Alternative hypothesis (H1)

There is a statistically significant relationship between Agni and newly diagnosed depression in the study population.

AIMS AND OBJECTIVES

Aim To evaluate the status of Jatharagni in individuals, newly diagnosed with depression.

Objectives To assess Jatharagni using a validated Agni Assessment Tool in both individuals newly diagnosed with depression and healthy controls.

To diagnose depression in individuals using the DSM-5 criteria.

To assess cognitive ability using the Clock Drawing Test in both individuals newly diagnosed with depression and healthy controls.

Depression will be assessed using the Hamilton Depression Rating Scale (HDRS).

Swasthya Assessment Scale will be used for evaluating the control group.

Secondary objective: To establish the relationship between Agni and newly diagnosed depression.

 
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