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CTRI Number  CTRI/2025/10/096498 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Cross Sectional Observational Study to evaluate the status of Jataragni, to examine salivary enzyme levels as indicators of digestion and to investigate the relationship between salivary enzyme markers and state of Jataragni in obese individuals and in control group. 
Scientific Title of Study   A Cross Sectional Observational Study on Jataragni Pareeksha in Sthoulya W.S.R. to Salivary Markers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K V Ankitha 
Designation  BAMS PG Scholar 
Affiliation  SDM college of Ayurveda Hospital and Research Centre Udupi 
Address  2nd year PG scholar Department of Roganidana evum Vikriti Vijnana SDM college of Ayurveda Hospital and Research Centre Udupi

Udupi
KARNATAKA
574118
India 
Phone  7760632748  
Fax    
Email  kvankitha7758@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar M 
Designation  Associate Professor 
Affiliation  SDM college of Ayurveda Hospital and Research Centre Udupi 
Address  Department of Roganidana evum Vikriti Vijnana SDM college of Ayurveda Hospital and Research Centre Udupi

Udupi
KARNATAKA
574118
India 
Phone  8951468755  
Fax    
Email  arunsdm@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K V Ankitha 
Designation  BAMS PG Scholar 
Affiliation  SDM college of Ayurveda Hospital and Research Centre Udupi 
Address  2nd year PG scholar Department of Roganidana evum Vikriti Vijnana SDM college of Ayurveda Hospital and Research Centre Udupi


KARNATAKA
574118
India 
Phone  7760632748  
Fax    
Email  kvankitha7758@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr K V Ankitha 
Address  2nd year PG scholar Department of Roganidana evum Vikriti Vijnana SDM college of Ayurveda Hospital and Research Centre Udupi  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K V Ankitha  SDM college of Ayurveda Hospital and Research Centre Udupi  2nd year PG scholar Department of Roganidana evum Vikriti Vijnana SDM college of Ayurveda Hospital and Research Centre Udupi
Udupi
KARNATAKA 		 7760632748

kvankitha7758@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Ayurveda Udupi Institutional Ethical Clearance Committee-Human  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individual 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Primary obese patients as per diagnostic criteria.
2. Participants aged between 18 to 60 years.
3. Willingness to participate in the study.
4. Provide informed consent for involvement in research activities.
5. Health Status
Absence of severe co morbidities affecting digestion.
Stable health condition without acute illnesses.
Control Group
Apparently Healthy Volunteers with BMI within the normal range of 18.5 to 23 kilogram per meter square. Participants aged between 18 to 60 years as per the Guidelines for Phase I clinical trials. 
 
ExclusionCriteria 
Details  1. Patients with obesity due to secondary causes like endocrine disorders or
medications.
2. Individuals below 18 or above 60 years of age.
3. Primary obesity with Presence of chronic diseases affecting digestion such as
inflammatory bowel disease, etc
4. Use of medications that can influence salivary enzyme levels or digestion like Proton
pump inhibitors Anticholinergic medications Antibiotics etc
5. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To Evaluate the status of Jataragni in individuals with primary obesity.
2. To Examine salivary enzyme levels as indicators of digestion in obese individuals.
3. To Investigate the relationship between salivary enzyme markers and the state of
Jataragni in obese patients.
4. To Compare between obese patients and a control group to understand salivary enzyme
levels in digestion patterns.  		 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   This is a Cross Sectional Observational Study to evaluate the status of Jataragni in individuals with primary obesity and examine salivary enzyme levels as indicators of digestion and investigate the relationship between salivary enzyme markers and state of Jataragni in obese patients and in control group. 
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