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CTRI Number  CTRI/2022/04/042123 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A CLINICAL AND IN-VITRO STUDY OF COMPLEXION EFfECT OF SWARNAPRASHAN 
Scientific Title of Study   CLINICAL AND IN-VITRO EVALUATION OF VARNYA (COMPLEXION ) EFFECT OF SWARNAPRASHAN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Ghritlahre 
Designation  P.G. Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  OPD no-07 Department of Kaumarbhritya, Shri N.P.A. govt Ayurvedic college Raipur C.G.

Raipur
CHHATTISGARH
492010
India 
Phone  8602871289  
Fax    
Email  nehaghritlahre96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrLowkesh Chandravanshi 
Designation  Lecturer Department of Kaumarbhritya 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  DEPARTMENT OF KAUMARBHRITYA, SHRI N.P.A. GOVT AYURVEDIC COLLEGE RAIPUR C.G.

Raipur
CHHATTISGARH
492010
India 
Phone  9827822231  
Fax    
Email  lowkeshc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Ghritlahre 
Designation  P.G. Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  OPD no-07 Department of Kaumarbhritya, Shri N.P.A. govt Ayurvedic college Raipur C.G.

Raipur
CHHATTISGARH
492010
India 
Phone  8602871289  
Fax    
Email  nehaghritlahre96@gmail.com  
 
Source of Monetary or Material Support  
Shri N.P.A. Govt Ayurvedic College Raipur C.G. 
 
Primary Sponsor  
Name  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Type of Sponsor  Government medical college 
 
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 Neha Ghritlahre  SHRI KHUDADAD DUNGAJI GOVT AYURVED HOSPITAL   OPD NO.7 DEPARTMENT OF KAUMARBHRITYA AND IPD PATIENT SHRI KHUDADAD DOONGAJI GOVT.AYURVEDA HOSPITAL RAIPUR CHHATTISGARH 492010 RAIPUR CHHATTISGARH
Raipur
CHHATTISGARH 		 8602871289

nehaghritlahre96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OFFICE OF THE PRINCIPAL ,SHRI NARAYAN PRASAD AWASTHI GOVERMENT AYURVEDA COLLEGE RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: varnya,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: SWARNAPRASHAN, Reference: KASHYAP SAMHITA SUTRA STHAN LEHA ADHAYAYY, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age of Children 4-12 years
Healthy Children
Children Will be Selected Irrespective of Caste Religion and Socioeconomic Status
 
 
ExclusionCriteria 
Details  Children suffering from any severe systemic disease like kidney diseases, heart diseases, skin diseases
Children not able to come at regular interval foe follow up
Chronic malnutrition
Pt. on long term medications corticosteroids, immunosuppressant
Diagnosed case of delayed milestone
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement of complexion,lustre of skin.  60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Develop immunity  60 Days 
 
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   N/A 
Date of First Enrollment (India)   30/04/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NILL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Ayurveda is the oldest system of medicine in the world ,it is the best way to achieve health and longevity. 
 In Ayurveda text meaning of  Varnya (complexion) has taken as Kanti of skin.
In Kashyap samhita ,Swarnaprashan is unique concept of lehan .Acharya Kashyap explained benifites of administration of Swarnaprashan as enhancing Medha(Intellect), Agni(Digestion),Balvardhanam(Strength),Ayushyam (Longevity), Mangalam ,Purnyam ,Vrishyam (Fertility) ,Varnyam(Complexioin), Grahapaham(Immunity).
Acharya Kashyap describes one of the benifits of Swarnaprashan is Varnya and no research work had done in past to evaluate this attribute of Swarnaprashan .So, keeping this context in mind, I have choosen tpo work on to re-evaluate the varnya (complexion) effrect of Swarnaprashan.
 
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