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CTRI Number  CTRI/2011/10/002040 [Registered on: 11/10/2011] Trial Registered Prospectively
Last Modified On: 26/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   TO CHECK THE EFFECT OF SKIN ANTI AGEING NUTRICOSMECTIC PRODUCT IN WOMEN 
Scientific Title of Study   TO EVALUATE THE EFFICACY OF A SKIN ANTI AGEING NUTRICOSMETIC IN WOMEN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/023/0711/STU   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation   
Address  C.L.A.I.M.S. Pvt. Ltd. 4th Floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai

Mumbai
MAHARASHTRA
400058
India 
Phone  66758851  
Fax  66758854  
Email  rsjdr@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation   
Address  C.L.A.I.M.S. Pvt. Ltd. 4th Floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai

Mumbai
MAHARASHTRA
400058
India 
Phone  66758851  
Fax  66758854  
Email  rsjdr@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Mr RB Mohile 
Designation  Managing Director 
Affiliation   
Address  C.L.A.I.M.S. Pvt. Ltd. 4th Floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W),

Mumbai
MAHARASHTRA
400058
India 
Phone  66758851  
Fax  66758854  
Email  rbmohile@claimscro.com  
 
Source of Monetary or Material Support  
Meiji India Private, Ltd. 703/A, Polaris Off Marol Maroshi Road, Behind Sangeet Plaza Marol, Andheri (East), Mumbai-400 059. 
 
Primary Sponsor  
Name  Meiji India Private Ltd 
Address  703/A, Polaris Off Marol Maroshi Road, Behind Sangeet Plaza Marol, Andheri (East), Mumbai-400 059. 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Rajiv Joshi   C.L.A.I.M.S. Pvt. Ltd.  4th Floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai-400058
Mumbai
MAHARASHTRA 		 66758851
66758854
rsjdr@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  with dry skin. Non vegetarians or consented vegetarian. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  7 g of Placebo Product +5.6g of Maltodextrin with other additives)   7 g of Placebo Product +5.6g of Maltodextrin with other additives) 1 sachet of Placebo to be taken dissolved in water taken in a container once daily for 30 days. Subjects may take a sachet with addition of 1 tea spoon sugar (3-5g). Product for personal use. To be stored at room temperature, away from light and moisture. Product for Human Participant trial. Keep out of reach of children.  
Intervention  MEIJI COLLAGEN  COLLAGEN PEPTIDE POWDER FORMULA (MEIJI COLLAGEN) (7 g of Test Product equivalent to 5 g fish collagen). 1 sachet of Product to be taken dissolved in water taken in a container once daily for 30 days. Subjects may take a sachet with addition of 1 tea spoon sugar (3-5g). Product for personal use. To be stored at room temperature, away from light and moisture. Product for Human Participant trial. Keep out of reach of children.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women with dry skin confirmed by taking 2. MoistureMeter SC readings (MoistureMeter SC Readings<20).
3. Phototype IV and below.
4. Food habit- Non vegetarians or consented vegetarian...
5. Subjects not on any nutritional supplement or not consuming any therapeutic medication for any disorder for last 45 days.
6. Subjects with no known allergies to foods & other substances.
7. Cooperating, informed of the need and duration of the study procedures, and ready to comply.
8. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
 
 
ExclusionCriteria 
Details  1. Subjects with any chronic illness or any clinical condition.
2. Subjects showing abnormal levels in blood test parameters. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator’s Discretion).
3. Pregnant Women (as confirmed via UPT) and lactating women.
4. Subjects with known allergies to food items like fish gelatine, soya, milk and milk products, egg, gluten etc and wheat flour.
5. Subjects with substance abuse (alcohol, drugs etc.)
6. Subject likely to undergo any surgery in the period of the study
7. Subjects who were on any other experimental Investigational study within last 1 month as identified during screening on visit 1 (V1).
8. Subjects unable to comply with the protocol in the opinion of Investigators.
9. Subjects who were not to maintain regular (orderly) life.
10. Subjects having any hard damage to skin (e.g. excessive sunburn or suntan).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in skin roughness and Wrinkle evaluation.
2. Skin Whitening effect evaluation
3. Skin elasticity
4. Skin Hydration
5. Self Evaluation 		 At Day 0 and Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Tolerance Evaluation  Week 4 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "67"
Final Enrollment numbers achieved (India)="67" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2011 
Date of Study Completion (India) 05/12/2011 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

·         This study will have 2 test products – a skin antiageing Nutricosmetic and 1 placebo.

·         During screening visit, following documentation of written informed consent of the volunteer, a detailed history will be taken from the volunteers by the Investigator.

·         Medical History and prior treatments taken by the volunteer would be recorded at screening visit.

·         Voluntary women in the age group of 30 – 50 years and with dry skin as confirmed by MoistureMeter SC readings will be recruited for the study. Dry skin readings via MoistureMeter SC lies between 0 – 20. Hence volunteers whose MoistureMeter SC readings are below 20 will be included. MoistureMeter SC readings for skin hydration will be taken on cheek.

·         All the subjects will undergo a blood test to determine her general health conditions for screening only.

·         At Visit 1 (D0) and Visit 2 (Week 4) the volunteers face will be washed with Cetaphil and volunteer will be acclimatized under controlled conditions (Temperature: 20â 22o C) and (Humidity: 40â60%) for 1 hour.

·         Measurements would be as follows: Silicon imprints for skin roughness and wrinkle evaluation of crows feet area

·         Spectrophotometer readings for skin whitening and Cutometer readings for skin elasticity will be taken on cheeks.

·         MoistureMeter SC readings for skin hydration will be taken on cheek.

·         Follow up visit will be at week 1 at a decided site and 4 weeks.

·         All measurements will be taken at both visits. Visit 1 (D0) and Visit 2 (4 weeks).

·         Digital Photographs will be taken at both visits.

Self Evaluation Questionnaire will be taken every week. At Week 1, the volunteers will be called to a previously specified place to fill in the self evaluation questionnaire. At week 2 and week 3 it will be taken telephonically. Volunteer will not be asked to come to the study centre for a visit.  
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