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CTRI Number  CTRI/2024/01/062048 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 29/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Rasasarata in individuals of different age group individuals.  
Scientific Title of Study   STUDY OF RASASARATA IN INDIVIDUALS OF DIFFERENT AGE GROUPS WITH SPECIAL REFERENCE TO SKIN MOISURE CONTENT-An observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Radhika Kalunge 
Designation  PG scholar 
Affiliation  PDEAS College of Ayurved and Research Centre  
Address  PDEAS College of Ayurved and Research Centre ,Kriya Sharir Department ,Ground floor ,Sector 25 ,Nigdi,Pune MAHARASHTRA 411044 INDIA

Pune
MAHARASHTRA
411044
India 
Phone  9404034478  
Fax    
Email  radhikakalunge83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Shweta More 
Designation  Associate Professer,MD Ayurved,Kriya Sharir Dept. 
Affiliation  PDEAS College of Ayurved and Research Centre 
Address  PDEAS College of Ayurved and Research Centre ,Kriya Sharir Department ,Ground floor ,Sector 25 ,Nigdi,Pune MAHARASHTRA 411044 INDIA

Pune
MAHARASHTRA
411044
India 
Phone  9730473931  
Fax    
Email  shwetmore85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Radhika Kalunge 
Designation   
Affiliation  PDEAS College of Ayurved and Research Centre 
Address  PDEAS College of Ayurved and Research Centre ,Kriya Sharir Department ,Ground floor ,Sector 25 ,Nigdi,Pune MAHARASHTRA 411044 INDIA

Pune
MAHARASHTRA
411044
India 
Phone  09404034478  
Fax    
Email  radhikakalunge83@gmail.com  
 
Source of Monetary or Material Support  
PDEA College of Ayurved and Research Centre ,Nigdi,Pune 411044 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research centre 
Address  PDEAS College of Ayurved and Research Centre ,Sector 25 ,Nigdi,Pune MAHARASHTRA 411044 INDIA 
Type of Sponsor  Private medical college 
 
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 
Vd Radhika Kalunge  PDEA College of ayurved and Research centre ,Sector 25 Pradhikaran ,Nigdi ,Pune  PDEA College of ayurved and Research centre ,Sector 25 Pradhikaran ,Nigdi ,Pune
Pune
MAHARASHTRA 
9404034478

radhikakalunge83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethic Committie  Not Applicable 
Institutional Ethics Committie  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preparatory instructions given to volunteers . 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Apparently Healthy individuals  
 
ExclusionCriteria 
Details  Individuals not willing to follow preparatory instructions for skin moisture content 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Particular type of rasasarata commonly found in particular age group  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Does Uttam rasasarata individulas having greater skin moisture content.   same as primary outcome 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   10/02/2024 
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="0"
Months="6"
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   In Ayurveda sara pariksha is one among the ten types of method to examine a patient,stated as Dashvidha pariksha .Sara pariksha primarly determines the stength and quality of a dhatu .Age wise pedominance of Dosha (Bala-Kapha ,Madhya-Pitta,jeerna-Vata )may have impact of rasadhatu .So an attempt has been made to study rasasarata in different age group individuals and to develop objectivity in term of skin moisture content measurement for rasasarata. 
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