| CTRI Number |
CTRI/2025/09/095362 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-ageing and anti-inflammatory activity of Miror Revive tablets |
|
Scientific Title of Study
|
An open label, Clinical study to Evaluate the anti-ageing and anti-inflammatory activity of Miror Revive tablets |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT802 Version 1.0 dated 21 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
|
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Miror Therapeutics Pvt Ltd, No 36, Rajhans Vasnthnagar, Bangalore, Karnataka, 560052 |
|
|
Primary Sponsor
|
| Name |
Miror Therapeutics Pvt Ltd |
| Address |
No 36, Rajhans Vasnthnagar, Bangalore, Karnataka, 560052 |
| 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 |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
09027285265
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Miror Revive Tablets |
Test Product: Miror Revive tablets, Dose: 1 Tablet after breakfast (OD), Route of Administration: Oral, test duration: 30 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Females from 30-55 years of age.
2. Females having Ageing (Fine Lines, Wrinkles, Age spots etc.) will be eligible for enrollment.
3. Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
4. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
2. Subjects that have participated in any other interventional clinical trial in the previous 90 days.
3. Subjects with known sensitivity to any of the constituents of the investigational product.
4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
5. Chronic illness which may influence the outcome of the study.
6. Pregnant/nursing mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. change in skin hydration
2. change in TEWL
3. Change in Skin firmness
4. change in C-Reactive Protein (CRP)
5. Erythrocyte Sedimentation Rate (ESR) |
At T0 and T30Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. SGA
2. Change in CASP-19(Control, Autonomy, Self-realization, and Pleasure-19) |
At Day1 and 30 day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Participants will receive the investigational product for a period of 30 days, with follow-up assessments conducted on Day 1 and Day 30. Enrollment will occur following confirmation of the subject’s age-ing diagnosis. At screening (Day 1), subjects will be enrolled based on the study’s inclusion and exclusion criteria. · Skin Firmness (Cutometer Assessment): (Day 0 & Day 30) · Skin Hydration (Corneometer): (Day 0 & Day 30) · TEWL (Tewameter): (Day 0 & Day 30) · CRP (C-Reactive Protein): (Day 0 & Day 30) · ESR (Erythrocyte Sedimentation Rate): (Day 0 & Day 30) · SGA(Subject Global Assessment)- Gut/Metabolism, Energy, Confusion, Poor memory, Difficulty in Concentrating, Fine Lines/Wrinkles, Age Spots, Dryness · CASP-19(Control, Autonomy, Self-realization, and Pleasure-19) Volunteers-40, Females from 30-55 years of age Subjects will be on study for up to 30 days. Screening and Baseline: Day 1 Telephonic Follow-up: Day 15
EOT- Day 30
|