| CTRI Number |
CTRI/2023/07/055135 [Registered on: 12/07/2023] 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 from Athos Collagen Pvt. Ltd. for Improving on Hair and Nail 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 Hair and Nail Health of Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/DER/083/23 Version 01 26-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 |
No. 128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor
Rangarajapuram Main Road, Kodambakkam, Chennai-600024. Tamilnadu, 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 |
Raam Clinic |
Room no 1, Department of General Medicine,
No. 128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor
Rangarajapuram Main Road, Kodambakkam, Chennai-600024. Tamilnadu, India
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 |
Clinically healthy adult subjects between the ages of 21 and 55 years (both ages and all genders inclusive) looking to improve their hair and nail 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 immediately. Treatment Duration : 90 days Route of Administration : Oral |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically healthy adult subjects between the ages of 21 and 55 years (both ages and all genders inclusive) looking to improve their Hair and Nail Health.
2. Subjects who have scored greater than or equal 15 in Hair and Nail Health Screening Questionnaire.
3. Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements (interventional) that are indicated at improving hair and nail health.
4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
5. 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 the ingredients of the investigational product
2. Subjects who are on collagens supplements in any form.
3. Subjects who are vegetarians/ vegans who object to consumption of animal origin investigational product.
4. Subjects who had an active dermatological procedure done up to 3 months prior to screening
5. Subjects who have skin condition/ scarring that prevent proper examination or evaluation of study criteria.
6. Subjects who have an active infection, disease or disorder that will prevent them 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 than1 month before screening.
11. 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., planed relocation) that the investigator felt would interfere with study evaluations and study participation.
12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocols.
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 |
1. m-Subjective Self Assessment: Hair Health : Total Score of less than or equal to 18 by end of the study.
2. m-Subjective Self Assessment : Nail Health: Total Score of less than or equal to 9 by end of the study.
3. Nail Fracturing Evaluation: Reduction by greater than or equal to 20 percentage by end of the study
4. IP Fracturing Questionnaire: total score of greater than or equal to 15 by end of the study.
|
1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90
2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90
3. Nail Fracturing Evaluation: Day 45, Day 90
4. IP Feedback Questionnaire: 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)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2023 |
| Date of Study Completion (India) |
16/11/2023 |
| 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 : An Open Label, Prospective,
Non-Randomised, Non- Comparative, Single Arm Clinical Study
Indication : Hair and Nail Health.
Investigational Product : FiColla from Athos Collagen Pvt. Ltd.
Comparator: Not Applicable. Non comparative
single arm study.
Dose/Dosage
Dose : 4 gram in
each sachet mixed with 100 ml lukewarm water
Dosage : Once a day for 90 days
Subject Population : Clinically healthy adult subjects
between the ages of 21 and 55 years (both ages and all genders inclusive)
looking to improve their hair and nail health.
Number of Subjects : 30 Evaluable Subjects
Treatment Arms : I
Treatment Duration : 90 Days (3 Months)
Efficacy Assessments
1.m-Subjective Self Assessment: Hair Health : Day 45, Day 90
2.m-Subjective Self Assessment: Nail Health : Day 45, Day 90
3.Nail Fracture Evaluation : Day 45, Day 90
4.IP Feedback Questionnaire : Day 90
Safety Assessments
1.Clinical Safety :
CBC, Serum Biochemistry: Day 01, Day 90
2.Monitoring adverse events : Day 01, Day 90
Background of the study: Hair and nail have psychological and
social importance throughout the ages in framing the personality and general
appearance of an individual. Healthy hair and nails are functionally and
cosmetically Important for both men and women in daily life. Marine collagen is rich in type 1 collagen
which can help in improving hair and nail health.
Purpose of the Study : Marine collagen showed to be
effective in cosmetics due to its antioxidant properties. The collagen metabolites
attracting fibroblast that generate the synthesis of new collagen. Thereby
marine collagen supplements improve the hair and nail health.
This clinical study is done to evaluate the safety and effectiveness of FiColla
of Athos Collagen Private Limited as a nutritional supplement for hair and nail
health of adults. |