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CTRI Number  CTRI/2021/12/038419 [Registered on: 03/12/2021] Trial Registered Prospectively
Last Modified On: 13/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To test irritation potential of Meera Small Onion Oil 
Scientific Title of Study   Evaluation of irritation potential of Meera Small Onion Oil through dermatological Evaluation by single occlusive patch test on Healthy adult human volunteers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan  
Designation  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY 605004 Pondicherry PONDICHERRY 605004 India

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722   
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan  
Designation  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY 605004 Pondicherry PONDICHERRY 605004 India


PONDICHERRY
605004
India 
Phone  9443627722   
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Sakthi Balan  
Designation  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY 605004 Pondicherry PONDICHERRY 605004 India


PONDICHERRY
605004
India 
Phone  9443627722   
Fax    
Email  saheerose@gmail.com  
 
Source of Monetary or Material Support  
CavinKare Private Limited, Cavinville, 12, Cenotaph Rd, Rathna Nagar, Alwarpet, Chennai, Tamil Nadu 600018  
 
Primary Sponsor  
Name  CavinKare Private Limited 
Address  Cavinville, 12, Cenotaph Rd, Rathna Nagar, Alwarpet, Chennai, Tamil Nadu 600018  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sakthi Balan   Thirumalai Speciality Clinic   Room no. 1.Diabetology OPD, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY 		 9443627722

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ki3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin sensitivity testing  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Meera Small Onion Oil, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar)
2. Age group of 18 to 55 years, 12 male and 12 female subjects.
3. Compliance with the study procedures involved.  
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Subjects with any other skin disorders.
3. Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of mean scores of Erythema/dryness/wrinkles, Oedema and Mean Irritation Index   Day 1,2,3 and 8 
 
Secondary Outcome  
Outcome  TimePoints 
occurrence of any adverse effects.   Day 1,2,3 and 8 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/12/2021 
Date of Study Completion (India) 11/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   24 adult healthy subjects will be selected for the study. The subjects selected for this study will be healthy males and females, aged between 18 and 55 years old of which 12 will be male and 12 will be female subjects. The entire study procedure, patch application, patch reading, grading is detailed in the protocol and followed as per the protocol. The patch applied contain Finn’s chamber within which 40, Micro Litre of the test/ Comparator product will be filled in a separate chamber. The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours. If the subject experiences any allergic reactions, the patch can be removed within 24 hours and reported to the investigators immediately. The mean scores of Erythema/ dryness/ wrinkles. oedema and Mean Irritation Index will be calculated on Day 1,2,3 and 8 
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