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CTRI Number  CTRI/2019/06/019494 [Registered on: 03/06/2019] Trial Registered Prospectively
Last Modified On: 03/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of PR/HC/1718/013 formulations in reducing dark spot, wrinkle, acne and improving skin even tone in healthy human volunteers. 
Scientific Title of Study   “Efficacy evaluation of PR/HC/1718/013 formulations in conferring dark spot reduction, wrinkle reduction, acne reduction and enhanced skin even tone in healthy human volunteers.” 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PR/HC/1718/013 Ver 1.0 dated 10Jan2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharad Dhawade 
Designation  Consultant 
Affiliation  Lokmanya Medical Research Center 
Address  OPD 2 Floor 4 Department of Ayurveda Lokmanya Medical Research Centre 314/ Telco Road Chinchwad Pune

Pune
MAHARASHTRA
411033
India 
Phone    
Fax    
Email  sharaddhawade123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Payal Gawali 
Designation  Manager 
Affiliation  Aayush Healthcare 
Address  Office No. D-117, Ground Floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035 Pune

Pune
MAHARASHTRA
411035
India 
Phone    
Fax    
Email  payalgawali.aayush@gmail.com  
 
Details of Contact Person
Public Query  
Name  Payal Gawali 
Designation  Manager 
Affiliation  Aayush Healthcare 
Address  Office No. D-117, Ground Floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035 Pune

Pune
MAHARASHTRA
411035
India 
Phone    
Fax    
Email  payalgawali.aayush@gmail.com  
 
Source of Monetary or Material Support  
Aayush Healthcare Office No. D-117, Ground Floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035 
 
Primary Sponsor  
Name  Aayush Healthcare 
Address  D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 
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 
Ms Varsha Bachkar  Lokmanya Medical Resaerch Centre  OPD 2, Floor 4 314/B Telco Road, Chinchwad, Pune
Pune
MAHARASHTRA 		 8446623333

bachkarvarsha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Aging skin with dark circle,acne and wrinkles 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  PR/HC/1718/013   Subjects will be advised to apply generous amount of cream twice daily on clean skin and affected area for 1 month.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Subject willing to give a written informed consent and come for regular observations
2.Subject is a healthy adult, male or female, in the age range of 18 and 40 years
3.Subject has at least 2 prominent wrinkles on crow feet area
4.Subject has at least 2 hyperpigmentary spots on face that are freckles, age spots, post inflammatory hyperpigmentation spots like post acne marks, etc on face
5.Facial acne, with: a. Inflammatory facial lesions (papules/pustules/nodules/cysts) b. Non inflammatory facial lesions if open (blackhead) and if closed (whitehead) comedones c. Mild to moderate acne with nodular abcesses
6.Subject has not participated in a similar clinical investigation in the past three months.
7.Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
8.Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.
9.Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
10.Female subjects of reproductive age group should undergo UPT at time of screening visit.
 
 
ExclusionCriteria 
Details  Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.
Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
Subject with excessive facial hair or scars, which could interfere with evaluation.
Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.
Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To Study the efficacy in reducing hyper pigmentation
2.To study the efficacy in reducing wrinkle.
3.To study the efficacy in reduction in acne lesion counts
4.To study Reduction in white and black heads, reduction in dark circles and redness on MASI scoring
5.Global Assessment Grade for improvement in complexion / dark spots on the face and neck
6.Patient Satisfaction Questionnaire, Feeling of looking better, Hydration and moisture to the skin, Radiance of the skin 		 Baseline, Day 15, Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period.
Assessment of Global evaluation of overall improvement in complexion on the face and neck by investigator and subject
 		 Baseline, Day 15, Day 30 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   05/06/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Subjects will be advised to apply cream twice daily on clean skin and affected area for 1 month.  The efficacy of product will be assesed for improvement in complexion, reduction in acne lesions, darkness, hyper pigmentation and wrinkles.

 
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