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CTRI Number  CTRI/2023/03/050690 [Registered on: 14/03/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Personal care product]  
Study Design  Other 
Public Title of Study   Safety evaluation of test products by PIPT on all healthy human with all skin types 
Scientific Title of Study   Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply on healthy human all skin types 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TG/CLI/071, Dated01 Mar 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B Sohandas Shetty 
Designation  Principal Investigator 
Affiliation  Trial Guna Pvt Ltd 
Address  467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560083
India 
Phone  8867125414  
Fax    
Email  drsohanshetty@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr B Sohandas Shetty 
Designation  Principal Investigator 
Affiliation  Trial Guna Pvt Ltd 
Address  467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka


KARNATAKA
560083
India 
Phone  8867125414  
Fax    
Email  drsohanshetty@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CRO Representative  
Affiliation  Trial Guna Pvt Ltd 
Address  467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560083
India 
Phone  9972636265   
Fax    
Email  meena@trialguna.com  
 
Source of Monetary or Material Support  
EMAMI LTD. EXPRESS ZONE A WING 7th FLOOR GOREGAON EAST MUMBAI - 400063  
 
Primary Sponsor  
Name  Emami Ltd 
Address  EMAMI LTD. EXPRESS ZONE A WING 7th FLOOR GOREGAON EAST MUMBAI - 400063  
Type of Sponsor  Other [FMCG] 
 
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 
Dr Sohandas Shetty  TrialGuna Private Limited   467, 2nd Floor,1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA 		 8867125414

drsohanshetty@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: zandu stress relief balm, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: emami AGNI BALM , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Phase I; Voluntary men and women ratio of 1:1 between 18 and 65 years.
● Phase II; Voluntary boy and girl ratio of 1:1 between 12 and 17 years.
● Having healthy skin on test area as assessed by dermatological examination.
● For whom the investigator considers that the compliance will be correct.
● Subjects with normal, dry, oily and combination skin 
 
ExclusionCriteria 
Details  Pregnant/nursing mothers.
● Scars, excessive terminal hair, or tattoo on the studied area.
● Dermatological infection/pathology on level of studied area.
● Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
● Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or
procedures. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of subjects that showed No significant irritation.
Score of less than or equal to 2 on the Draize scale. 		 Baseline, Visit 2,Visit 3, Visit 4, Visit 5 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 16/03/2023 
Date of Study Completion (India) 23/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Phase I of the study will involve 24 healthy adult human subjects with Male & Female ratio of 1:1, will be tested for Zandu Stress Relief Balm and Emami Agni Balm. b. Phase II of the study will involve 24 healthy adolescent human subjects with Male & Female ratio of 1:1, will be tested for Zandu Stress Relief balm.  
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