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CTRI Number  CTRI/2019/06/019857 [Registered on: 25/06/2019] Trial Registered Prospectively
Last Modified On: 13/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study on Collagen Peptide of Titan Biotech Limited for Skin, Nail and Hair Health in Adults. 
Scientific Title of Study   A Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Collagen Peptide of Titan Biotech Limited in the Skin, Nail and Hair Health of Adult Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AHC/DER/055/19 Version 01 dated 31-may-19  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VT Sriraam 
Designation  Principal Investigator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VT Sriraam 
Designation  Principal Investigator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VT Sriraam 
Designation  Principal Investigator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Titan Biotech Limited Unit I: A-902 A, RIICO Industrial Area, Phase III, Bhiwadi - 301019. Rajasthan. India.  
 
Primary Sponsor  
Name  Titan Biotech Limited 
Address  Unit I: A-902 A, RIICO Industrial Area, Phase III, Bhiwadi - 301019. Rajasthan. India.  
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 VT Sriraam  Raam Clinic  Room no. 1 180/109, G1, RR Villa, Rangarajapuram Main Road, Kodambakkam
Chennai
TAMIL NADU 		 9840909155

md@auroushealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Universal Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General improvement in Skin, Nail and Hair Health 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Collagen Peptide (Bovine)  5g of product to be dissolved in warm water and consumed once a day, for 90 days 
Intervention  Collagen Peptide (fish)  5g of product to be dissolved in warm water and consumed once a day, for 90 days 
Comparator Agent  Placebo  5g of product to be dissolved in warm water and consumed once a day, for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Adults between 18 and 45 years of age (both ages and all sexes inclusive)
2. Subjects with any skin type with a minimum of one concern
i. Wrinkles
ii. Dry, Dull Skin
iii. Brittle Nails
iv. Dry, Dull Hair
v. Hair Fall, Breakage
vi. Split Ends of the hair
3. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
 
 
ExclusionCriteria 
Details  1. Subjects with known hypersensitivity to investigational product or its constituents.
2. Subjects who have skin condition that prevent proper examination or evaluation of study criteria.
3. Subjects who are on active treatments for skin and/or hair conditions.
4. Subjects who have dyed their hair in the last 60 days.
5. Subjects with immunucompromised state complications.
6. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
7. Females who are pregnant or lactating or planning to become pregnant during the study period.
8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Skin Improvement Questionnaire : Total Score of ≥20 by end of study
2. 60 Second Hair Count Test: Reduction of ≥20% by end of study
3. Hair Growth Questionnaire : Total Score of ≥20 by end of study
4. Nail Health Questionnaire: Total Score of ≥20 by end of study
 		 1. Skin Improvement Questionnaire : Day1,Day 45, Day 90
2. 60 Second Hair Count Test: Day1,Day 45, Day 90
3. Hair Growth Questionnaire : Day1,Day 45, Day 90
4. Nail Health Questionnaire:Day1,Day 45, Day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2019 
Date of Study Completion (India) 30/09/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Study Design: Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study.
Indication: Skin, Nail and Hair Health
Investigational Product Test 1: Collagen Peptide (Fish Source)
Investigational Product Test 2: Collagen Peptide (Bovine Source)
Comparator: Placebo
Study Population: 72 Subjects; Adults between 18 and 45 years of age (both ages and all sexes inclusive).
Treatment Duration: 3 Months (90 Days)


RESULTS OF THE CLINICAL STUDY

Skin Improvement Questionnaire

Bovine Collagen: 46% of Subjects in this treatment group have achieved a Score of >20 in Skin Improvement Questionnaire in 90 Days. (Z = –0.39, p = 0.653 > 0.05). End Point NOT Achieved.

Fish Collagen: 100% of Subjects in this treatment group have achieved a Score of >20 in Skin Improvement Questionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05). End Point Achieved.

Placebo: 0% of Subjects in this treatment group have achieved a Score of >20 in Skin Improvement Questionnaire in 90 Days. (Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved.

Fish Collagen vs Placebo: 100% of Subjects in “Collagen (Fish) group” have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Skin Improvement Questionnaire in 90 Days.

Bovine Collagen vs Placebo: 46% of Subjects in “Collagen (Bovine) group” have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Skin Improvement Questionnaire in 90 Days.

Bovine Collagen vs Fish Collagen: Only 46% of the subjects in “Collagen (Bovine) group” have achieved a Score of >20 in Skin Improvement Questionnaire in 90 Days, while 100% of subjects (i.e., all the subjects) have achieved such reduction in “Collagen (Fish) group”.

 

60 Second Hair Count Test

Bovine Collagen :  50% of Subjects in this treatment group have achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = 3.88, p = 0.000 < 0.05). End Point NOT Achieved

Fish Collagen:  100% of Subjects in this treatment group have achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = 4.90, p = 0.000 < 0.05).End Point Achieved

Placebo:  0% of Subjects in this treatment group have achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved.

Fish Collagen vs Placebo:  100% of Subjects (i.e., all the subjects) have achieved 20% reduction in “Collagen (Fish) group” whereas, 0% of subject in Placebo group achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days.

Bovine Collagen vs Placebo: 50% of Subjects in “Collagen (Bovine) group” have achieved a reduction of 20% whereas, 0% of subject in Placebo group achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days.

Bovine Collagen vs Fish Collagen:  50% of the subjects in “Collagen (Bovine) group” have achieved a reduction of at least 20% in Hair Count Test score, whereas, 100% of subjects (i.e., all the subjects) have achieved such reduction in “Collagen (Fish) group”.

Hair Growth Questionnaire

Bovine Collagen:  42% of Subjects in this treatment group have achieved a Score of >20 in Hair Growth Questionnaire in 90 Days. (Z = –0.78, p = 0.784 > 0.05). End Point NOT Achieved

Fish Collagen:  100% of Subjects in this treatment group have achieved a Score of >20 in Hair Growth Questionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05).End Point Achieved

Placebo: 0% of Subjects in this treatment group have achieved a Score of >20 in Hair Growth Questionnaire in 90 Days. (Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved

Fish Collagen vs Placebo: 100% of Subjects in “Collagen (Fish) group” have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Hair Growth Questionnaire in 90 Days.

Bovine Collagen vs Placebo: From Visit 1 to Visit 3: According to the result of Single Proportion Test, 42% of Subjects in “Collagen (Bovine) group” have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Hair Growth Questionnaire in 90 Days.

Bovine Collagen vs Fish Collagen:  From Visit 1 to Visit 3: According to the result of Two-Proportion test, the null hypothesis is rejected at 5% level of significance (Z = –4.45,p = 0.000 < 0.05). Only 42% of the subjects in “Collagen (Bovine) group” have achieved a Score of >20 in Hair Growth Questionnaire in 90 Days, while 100% of subjects (i.e., all the subjects) have achieved such reduction in “Collagen (Fish) group”

 

Nail Health Questionnaire

Bovine Collagen:  42% of Subjects in this treatment group have achieved a Score of >20 in Nail Health Questionnaire in 90 Days. (Z = –0.78, p = 0.784 > 0.05). End Point NOT Achieved

Fish Collagen:  100% of Subjects in this treatment group have achieved a Score of >20 in Nail Health Questionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05).End Point Achieved

Placebo: 0% of Subjects in this treatment group have achieved a Score of >20 in Nail Health Questionnaire in 90 Days. (Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved

Fish Collagen vs Placebo: 100% of Subjects in “Collagen (Fish) group” have achieved a Score of >20 whereas, 0% of subject in Placebo Group achieved a score of >20 in Nail Health Questionnaire in 90 Days.

Bovine Collagen vs Placebo: 42% of Subjects in “Collagen (Bovine) group” have achieved a Score of >20 whereas, 0% of subject in Placebo Group have achieved a score of >20 in Nail Health Questionnaire in 90 Days.

 Bovine Collagen vs Fish Collagen:  42% of the subjects in “Collagen (Bovine) group” have achieved a Score of >20 in Nail Health Questionnaire in 90 Days, while 100% of subjects (i.e., all the subjects) have achieved such reduction in “Collagen (Fish) group”. 

Safety Results

No adverse event was reported in this clinical study. The safety investigations also showed no clinical difference from baseline to end of the study.

Overall Study Conclusion: Overall, it is concluded that Fish Collagen was effective in the improving skin, hair and nail health in 90 days.  No adverse event was reported upon consumption of both Bovine Collagen and Fish Collagen. The safety investigations also showed no clinical difference from baseline to end of the study.  Based on the results of this Clinical Study Report, Fish Collagen Peptide of Titan Biotech Limited/Stalwart Nutritions Pvt. Ltd is recommended as a safe and effective therapy in the improving skin, hair and nail health.


 
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