| CTRI Number |
CTRI/2023/07/055042 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Fish Collagen of Athos Collagen Pvt. Ltd for improving Skin Health |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study the Effectiveness, Safety and Tolerability of “FiColla†from Athos Collagen Private Limited as a Nutritional Supplement for Skin Health of Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/DER/082/23 Version 01 28-Apr-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room no 1, Department of General Medicine
Division of Research and Development
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room no 1, Department of General Medicine
Division of Research and Development
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room no 1, Department of General Medicine
Division of Research and Development
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Athos Collagen Private Limited
319,Blue Eminence, Opp.Sangini Gardenia, Jahangirpura-Dandi Road ,Surat,395005,Gujarat.
|
|
|
Primary Sponsor
|
| Name |
Athos Collagen Private Limited |
| Address |
No.319,Blue Eminence, Opp.Sangini Gardenia,
Jahangirpura-Dandi Road Surat,395005,Gujarat
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor,
Rangarajapuram Main Road , Kodambakkam, Chennai 600024 Tamil Nadu, India
|
|
|
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 |
Aurous HealthCare Research and Development India Pvt Ltd |
Room no 1, Department of General Medicine
Division of Research and Development
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam
Chennai 600034.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers looking to improve Skin Health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FiColla from Athos Collagen Pvt. Ltd. |
Dose : 4 gm in one sachet
Dosage : One sachet to be emptied into 100ml luke warm water,mixed well and consumed immedaitely.
Treatment Duration : 90 days
Route of Administration : Oral
|
| Comparator Agent |
Not applicable. Single Arm Study |
Not applicable. Single Arm Study |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically Healthy adult subjects between the age of 30 and 55 years ( both ages and all genders inclusive) looking to improve their skin health.
2. Subject with fine lines and wrinkles.
3. Subject who are willing to abstain from the use of herbal , allopathic or other nutritional Supplements (intervention) that are indicated at improving skin health.
4. Subjects who are rated as Grade 2-4 on the Wrinkle Severity Scale.
5. Subject who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
6. Subjects who are willing not to participate in any other clinical trail during participation in the current trail.
|
|
| ExclusionCriteria |
| Details |
1. Subject with Known hypersensitivity to the ingredients of the investigational product
2. Subjects who are on Collagen supplements in any form.
3. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product
4. Subjects who are on tropical treatments /regimens (prescribed, clinical or self) of retinol, vitamin C, bakuchiol, peeling treatments of AHA, BHA, Glycolic Acid or any combination thereof aimed at improvement skin texture, hyperpigmentation, pore size.
5. Subjects who have an active dermatological procedure done up to 3 months prior to screening.
6. Subjects who have an active infection, disease or disorder that will prevent from fully satisfying the responsibilities of the study.
7. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
8. Subjects on remission from cancer of any type less than 5 years at the time of screening.
9. Subjects who are planning a pregnancy and/or currently breastfeeding.
10. Subjects who have participated in a clinical study less than 1 month before screening.
11. Any significant medical condition (eg., 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.
12. Subject who mentally unable to comphrened the responsibilities and adhere to the stipulations protocol.
13. Subjects, who in the opinion of the investigator are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective visual Assessment : m-Danielle’s Criteria : Reduction of greater than equal to 1 score from baseline.
Clinical Grading of Skin : Reduction of greater than equal to 20% percentage in total score from baseline.
Subjective Assessment of Cosmetic Effects : Total Score of lesser than equal to 15 by end of the study.
IP Feedback Questionnaire : Total Score of greater than or equal to 15 by end of the study
|
Objective visual Assessment : m-Danielle’s Criteria : Day 01, Day45, Day 90
Clinical Grading of Skin : Day 01, Day45, Day 90
Subjective Assessment of Cosmetic Effects : Day45, Day 90
IP Feedback Questionnarie : Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2023 |
| Date of Study Completion (India) |
16/10/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : Open label, Prospective , Non-Randomized, Non-Compartive Single Arm
Clinical Study
Indication :
Skin Health
Investigational Product : FiColla
Comparator: Not
Applicable. .Single Arm Non Comparative Study
Dose/Dosage
Dose : 4grams in each sachet
Dosage :One sachet to be emptied into 100 ml luke warm water, mixed well
and consumed immediately.
Subject Population : Clinically healthy adult subjects between the ages of 30 and 55
years (both ages and all genders inclusive) looking to improve their skin
health.
Number of Subjects : 30 Evaluable Subjects
Treatment Arms : I
Treatment Duration : 90 days
Efficacy Assessments
Objective visual Assessment : m-Danielle’s Criteria
: Day 01, Day 45, Day 90
Clinical Grading of Skin : Day 01, Day45, Day 90
Subjective Assessment of Cosmetic Effects : Day45, Day 90
IP Feedback Questionnaire : Day 90
Safety Assessments
Clinical Safety : CBC, Serum Biochemistry
Monitoring adverse events
Background of the study: The skin is an essential organ in the human body that serves as a
barrier against external environmental factors like sunlight, temperature,
dust, bacterial infection, and so on. Collagen is the buliding block protein of
our skin. As we become older , the amount of collagen in the body gets low.
This makes the skin became less elastic and makes fine lines. Collagen
supplements reduce the signs of aging such as wrinkles and fine lines by
improving the structure of skin.
Purpose of the Study : Collagen-based supplements have become a keystone in the management
of the ageing process, with proven ability to repair skin damage, bestowing a
youthful and healthy appearance sought in the pursuit of beauty. Collagen is an
essential scaffold protein that gives smoothness and elasticity to skin, but
its production declines with age. A
growing number of scientific studies show exciting evidence that it is possible
to rejuvenate ageing or damaged skin, improve function of worn joints, and
support personal wellbeing and vitality. In recent times, research on the
mechanisms which impact the production of collagen in skin and the ideal
organization into functional fibres which give skin its characteristic
elasticity and firmness has provided new insights into how this bio-scaffold
can support cells, tissues and organs.
This clinical study is done to evaluate the
safety and Effectiveness of FiColla of Athos Collagen Private Limited as a
Nurtitional Supplement for skin health of adults. |