| CTRI Number |
CTRI/2025/09/094995 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptomatic Relief with Miror BLISS tablets in patients having Menopause and Peri-menopause |
|
Scientific Title of Study
|
An open Label, Clinical Study to Evaluate the Symptomatic Relief with Miror BLISS tablets in patients having Menopause and Peri-menopause |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT844 Version 1.0 dated 21 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha Sharma |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7217245093 |
| Fax |
|
| Email |
shikhasharmagyno@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
Meerut
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, UTTAR PRADESH, 250005-India |
| 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 Shikha sharma |
CCFT laboratories |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
72172 45093
shikhasharmagyno@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 |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Miror BLISS tablets |
Dose: 1 tablet per day after dinner (OD)
Route of Administration: Oral
Duration-28 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Females from 35-55 years of age.
2. Females having Menopause and Peri-Menopause 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. Estrogen( Estradiol, Estrone, Estriol)
2. SGA(Subject Global Assessment)
|
Time points: Day 1 and 28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. MENQOL
|
Time points: Day 1 and 28 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)
|
25/09/2025 |
| 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="0"
Days="28" |
|
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
|
An
Open Label, Single arm clinical study.
Each
participant entering the trial will be assigned to a regimen of investigational
product, and advised to take general precautions as needed.
Participants
will receive the investigational product for a period of 28 days, with
follow-up assessments conducted on Day 1 and Day28.Enrollment will occur following confirmation of the subject’s Menopause and
Perimenopause diagnosis
At screening (Day 1), subjects will be enrolled based on the study’s inclusion
and exclusion criteria.
The following assessments will be conducted on Day 1 and 28 day:
·
Estrogen( Estradiol, Estrone, Estriol)
·
SGA(Subject Global Assessment)
o Hot
Flashes
o Night
Sweats
o Mood
Swings
o Disturbed
sleep
o Dizziness
o Muscle
Aches
o Breast
tenderness
o Palpitation
· MENQOL Subjects will
be on study for up to 28 days. Screening and Baseline: Day
1, Telephonic
Follow-up: Day 15, End Visit: Day 28 |