| CTRI Number |
CTRI/2025/02/081060 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Anti-Ageing Potential of Silphion Oral Collagen Powder |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-Ageing Activity of Silphion Oral Collagen Powder on Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT483 Version 1.0 dated 23 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
|
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India 250002 |
| Silphion Research Pvt Ltd, 4th Floor First Mall Road Gandhi Nagar Chennai City, Chennai-600020 |
|
|
Primary Sponsor
|
| Name |
Silphion Research Pvt Ltd |
| Address |
4th Floor First Mall Road Gandhi Nagar Chennai City, Chennai-600020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, Delhi Road
Meerut
UTTAR PRADESH |
9027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test Product: Oral Collagen Powder 5 gms per day |
Test Product: Oral Collagen Powder, Take 5 grams of collagen powder daily. Add the powder to 100-150 ml of water, stir well, and drink. Application: Once a day, Route of administration: Oral, Duration: 28 days |
| Comparator Agent |
Test Product: Oral Collgen Powder 10gms per day |
Test Product: Oral Collagen Powder, Take 10 grams of collagen powder daily. Add the powder to 100-150 ml of water, stir well, and drink. Application: Once a day, Route of administration: Oral, Duration: 28 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Non-pregnant, non-lactating female aged between 30 to 55 (Female:Male ratio to be 80:20)
2) Subjects willing to give written informed consent
3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
4) Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5) Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3.Volunteers Allergic to Fish.
4.Volunteers Taking long term medication.
5.Have participated in any interventional clinical trial in the previous 30 days.
6.Have a known sensitivity to any of the constituents of the test product including sensitivities to (mention some of active ingredient’s name)
7.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
8.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Melanin index by mexameter
2. Change in Hydration by cornemeter
3. Change in Elasticity
4. Change in water loss through skin by TEWL
5. Change in Wrinkles and blemishes by Visio Scan
6.Change in under eye dark circle |
At t0 and t28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
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
Modification(s)
|
To Check safety and efficacy of oral collagen
Total Volunteers: 50 participants Dose: 1. 25 volunteers will take 5 grams per day for 28 days. 2. 25 volunteers will take 10 grams per day for 28 days
Measurements and images for the following: 1. Melanin index 2. Lightning index 3. Hydration 4. Elasticity 5. Wrinkles in the crow’s feet area 6. Blemishes ( 3D images and evaluation by specialist) 7. Under-eye dark circles
It is a Randomized study design
Total Duration- 28 Days Follow ups- Day0, Day28 |