| CTRI Number |
CTRI/2025/10/096210 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate the Safety and Effectiveness of Mirror PCOS Advanced Care Tablets in Women with Polycystic Ovary Syndrome (PCOS) |
|
Scientific Title of Study
|
An Open-Label, Single-Arm, Single-Center, Phase 3 Clinical Study To Evaluate The Safety And Efficacy Of Mirror Pcos Advanced Care Tablets In Subjects With Polycystic Ovary Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2521 Version No 1.0 Dated 01 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suguru Vasudha |
| Designation |
Principal Investigator |
| Affiliation |
Sri Lakshmi Super Speciality Hospital |
| Address |
CR Unit, 4th floor, #301, 3rd Main Road, Old Extension, KR Puram,
Bangalore
KARNATAKA
560036
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
drsuguru.vasudha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Miror Therapeutics Private Limited
No. 36, Rajhans, Ground Floor, 7th Cross, Vasanthnagar, Bangalore, B.B.M.P East, Karnataka -560052 |
|
|
Primary Sponsor
|
| Name |
Miror Therapeutics Private Limited |
| Address |
No. 36, Rajhans, Ground Floor, 7th Cross, Vasanthnagar, Bangalore, B.B.M.P East, Karnataka -560052 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suguru Vasudha |
Sri Lakshmi Super Speciality Hospital |
CR Unit, 4th floor, #301, 3rd Main Road, Old Extension, KR Puram,
Bangalore
KARNATAKA |
06364898825
drsuguru.vasudha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mirror PCOS Advanced Care Tablets |
Subjects will receive Mirror-PCOS Advanced Care Tablets, 1 tablet orally once daily after breakfast for a total duration of 30 consecutive days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Age and Sex: Female participants aged 18–35 years at the time of informed consent.
2. Diagnosis- Clinically diagnosed with Polycystic Ovary Syndrome (PCOS) based on Rotterdam 2003 criteria.
3. General Health: Subjects with stable general health, without any acute illness or uncontrolled chronic condition that could interfere with study outcomes.
4. Contraception: If sexually active, willing to use a reliable non-hormonal contraceptive method during the study and provide a negative urine pregnancy test at Baseline.
5. Compliance: Willing and able to comply with the study requirements, including completing all scheduled visits, laboratory assessments, and questionnaires.
6. Informed Consent: Capable of understanding the study requirements and providing written informed consent prior to participation. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and Lactation: Pregnant or breastfeeding women.
2. Recent Surgery or Trauma: History of recent major surgery, hepatic failure, or significant trauma within the last 3 months.
3. Concurrent Illness: Presence of major systemic illnesses including:
o Bronchial asthma,
o Hematological disorders,
o Malignancies,
o Cardiovascular disease,
o Carcinoma,
o Severe renal or hepatic dysfunction.
Protocol No.: CTSRS/2521 Confidential Page 16 of 35
Ver./Date: 1.0/01 Sep 2025
4. Medication Use:
o Current or recent (within 3 months) use of hormonal contraceptives, anti-androgens, ovulation induction agents, or insulin-sensitizing drugs (e.g., metformin, pioglitazone).
o Current participation in another interventional drug study or use of investigational products within the past 3 months.
5. Allergies: Known allergy or intolerance to any of the investigational product ingredients.
6. Other Endocrine Disorders: Presence of other causes of anovulation/hyperandrogenism such as:
o Non-classical congenital adrenal hyperplasia,
o Cushing’s syndrome,
o Hyperprolactinemia,
o Androgen-secreting neoplasms,
o Thyroid dysfunction.
7. Substance Use: Current smokers, alcohol or substance abuse that could interfere with adherence to study procedures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Metabolic-Mean change in fasting blood glucose (milligrams per deciliter) from Baseline visit to Day Thirty.
Reproductive or Ovarian- Mean change in antral follicle count and ovarian volume (cubic centimeters) by pelvic ultrasound from Screening or Baseline to Day Thirty.
Stress Axis Biomarker- Mean change in serum cortisol (micrograms per deciliter) from Screening or Baseline to Day Thirty. |
Screening (Day –7 to 0),
Baseline (Day 0),
Day 15 ±2 Days,
Day 30 ±2 Days (EOS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nutritional and Functional Status- Change in Subject Global Assessment score from Screening or Baseline to Day Thirty.
Quality of Life- Change in World Health Organization Quality of Life BREF domain scores from Screening or Baseline to Day Thirty.
Safety and Tolerability- Incidence, severity, seriousness, and relationship of adverse events and serious adverse events recorded across Thirty days. Proportion of subjects discontinuing due to adverse events. Clinically significant changes in laboratory safety parameters including fasting blood glucose, cortisol, and ultrasound findings. |
Screening (Day –7 to 0),
Baseline (Day 0),
Day 15 ±2 Days,
Day 30 ±2 Days (EOS) |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Summary of the Study:
This Phase 3, open-label, single-arm, single-center study investigates the effect of a nutraceutical intervention in women with Polycystic Ovary Syndrome (PCOS). PCOS is a common hormonal disorder marked by ovarian dysfunction, hyperandrogenism, and polycystic ovarian morphology, often accompanied by insulin resistance, metabolic changes, and stress-axis dysregulation. Existing treatments, including lifestyle changes, oral contraceptives, insulin sensitizers, and anti-androgens, often have limited efficacy or tolerability, highlighting the need for complementary, safe interventions.
The study will evaluate the nutraceutical’s impact on metabolic health (fasting blood glucose), ovarian morphology (follicle count and ovarian volume), stress-axis function (serum cortisol), and patient-centered outcomes (quality of life and nutritional status) over 90 days.
Purpose of the Study:
The study aims to assess the safety and tolerability of the nutraceutical, identify preliminary efficacy signals on metabolic, reproductive, and stress-related outcomes, and generate data for planning future randomized trials, including effect sizes, feasibility, and operational insights such as recruitment and adherence. It also seeks to provide a holistic assessment of PCOS by integrating clinical, biochemical, imaging, and patient-reported outcomes. |