| CTRI Number |
CTRI/2025/09/094471 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving PCOS Outcomes Through Protein and Micronutrient Supplementation – MIRACLE-PCOS Trial |
|
Scientific Title of Study
|
Protein and Micronutrient Intervention for Regulating Androgen Levels and Correcting Lifestyle Associated Effects in Polycystic Ovary Syndrome (PCOS) (MIRACLE-PCOS Study) - An Open label, Interventional, Multicenter, Non-randomized, Single-arm, Proof of Concept Study |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| C3B05830; DRL-IND-GGI-106-CELE/2025; Ver 02, Dated 30 Sep 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simran Sethi |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Mori |
| Designation |
Medical Monitor |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana Bhoite |
| Designation |
Head-Nutrition Science & Clinical Nutrition, Nutraceutical |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories,
8-2-337, Road No. 3, Banjara Hills,
Hyderabad-500034, Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
9871969876 |
| Fax |
|
| Email |
rachanamb@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddy’s Laboratories Ltd., Medical Affairs Department, 7-1-27, Ameerpet, Hyderabad, Telangana – 500016, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet,
Hyderabad, Telangana - 500016 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Santwani |
360-degree Healthcare Studio |
Office A3, Liberty House,
N Main Rd, Opp. Lane 5,
Above My Jio Store,
Liberty Phase 2,
Ragvilas Society,
Koregaon Park, Pune,
Maharashtra-411001.
Pune
MAHARASHTRA |
9822025023
dr.ritusantwani@gmail.com |
| Dr Nisha Balasaheb Ghumare |
Aundh Institute of Medical Sciences (AiMS) |
Hospital & Research center. S. No 154, Near AiMS Square, Aundh, Pune, Maharashtra 411007
Pune
MAHARASHTRA |
8108387667
drnisha.clinicaltrials@gmail.com |
| Dr Pranjali Suryawanshi |
Life point multispecialty hospital |
Sr. No 145/1,
Mumbai-Banglore Highway,
Near Hotel Sayaji,
Waked, Pune,
Maharashtra - 411057
Pune
MAHARASHTRA |
9119562914
drpranjalisuryawanshi@gmail.com |
| Dr Manali Parmar |
Shree Pragati Foundation’s Hira Mongi Navneet Hospital |
Shree Pragati Foundation’s Hira Mongi Navneet Hospital,
Valji Ladha Road,
NR Kalidas Natyagrah,
Mulund, West Mumbai,
Maharashtra - 400080
Mumbai (Suburban)
MAHARASHTRA |
9819350252
drmanaliparmarhmnh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Lifepoint Research- Ethics Committee |
Approved |
| Penta- Med Ethics Committee |
Approved |
| Skinovate Independent 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 |
Celehealth Myoshape (Protein, Myo inositol, D-chiro inositol and micronutrient-based supplement) |
One heaped scoop of the test product in 200 ml lukewarm water, consumed within 20 minutes as a replacement for one major meal daily during the treatment period (i.e., 3 months of IP consumption). |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Non-pregnant /non-lactating females.
2) Overweight and Obese participants with BMI range from 23 kg/m2 to 35 kg/m2
3) Participants with HbAlC below 6.5 % (normal and prediabetic participants)
4) Participants with PCOS and with presence of any two of the following parameters (Rotterdam criteria):
o Clinical hirsutism (Ferriman-Gallwey score of greater than or equal to 4 to greater than or equal to 8 or as per clinical judgement) or biochemical hyperandrogenism (only total testosterone- greater than 50 ng/dL)
o evidence of oligo-anovulation (oligo amenorrhea (cycles more than 35 days apart or less than 8 menses a year)
o polycystic appearing-ovarian morphology on ultrasound, with exclusion of other relevant disorders. (Greater than or equal to 20 follicles per ovary in either ovary or greater than or equal to 10 cm3 ovarian volume)
5) Participants with a Menstrual Cycle length of 25 - 50 day.
6) Participants who have completed a one-month washout period, in case of any hormone treatments within the last 24 weeks. |
|
| ExclusionCriteria |
| Details |
1) Participants with hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4 and TSH)
2) Participants who have received any drugs to support conception.
3) Participants with presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hyper/hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushings syndrome / with a suspected adrenal or ovarian tumor secreting androgen.
4) Participants who have undergone major surgery of any organ system in the opinion of PI and defined in terms of factors like significant patient comorbidity, key surgical parameters (long operative duration, organ ischemia, blood loss more than 1000mL, high vasopressor use), post operative metabolic stress response, 30-day morbidity, more than 2% and the need for intermediate or intensive care in the past 1 month.
5) Participants on confounding medications which affect ovarian function including metformin (Participants who were using metformin and who have completed a one-month washout period, can be included in the study) or Using insulin sensitizing drugs or Any pharmacotherapy capable of interfering with glucose metabolism or any drug to support conception.
6) Participants undergoing treatment with products containing inositol in the previous 3 months.
7) Hospitalization for an infectious condition within 4 weeks prior to study entry.
8) Participants who are allergic to the ingredients (Myo-inositol, INS 460 (i), Alpha-lipoic acid, Minerals, Inositol (D-chiro), Vitamins) of the interventional product.
9) Participants actively trying for conception via ART Therapy.
10) Any other condition in the opinion of the Principal Investigator which may interfere with study results and affect the participants safety.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of change in dietary intake using 3-day dietary recall
2. Assessment of Androgen-associated outcomes
3. Assessment of Glucose metabolism outcomes and insulin resistance |
1. Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption)
2. Screening Visit (only for TT), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption)
3. Screening Visit (only for HbA1c), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Assessment of Androgen-associated outcomes |
Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) |
| Assessment of characteristics associated with PCOS |
Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) |
| Assessment of Body Outcomes |
Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) |
| Assessment of Lipid metabolism outcomes |
Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) |
| Assessment of menstrual cycles associated parameters |
Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) |
Assessment of parameters related to Infertility
(a) Size of Ovary by Ultrasound Scanning
(b) Conception, if any.
|
(a) Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption)
(b) Visit 01P (Baseline), Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="6"
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
|
This is an open label, interventional,
multicenter, non-randomized, single-arm, proof of concept study to assess the
safety and efficacy of high protein and micronutrient intervention in
regulating the androgen levels and correcting lifestyle associated effects in
participants with Polycystic ovary syndrome (PCOS).
The potential participants will be screened as
per the inclusion and exclusion criteria only after obtaining written informed
consent from the participants.
Total Study Duration: Approximately 6 months - Treatment Period: 3 months - Follow-up Period: Up to 50 days after 3-months
of IP Consumption
Study
visits:
The study will consist of a total of 08 visits, i.e., 04 physical and 04
telephonic visits.
All eligible participants will undergo clinical
assessments, laboratory assessments and subjective assessments. Safety will be
assessed throughout the study by monitoring adverse events. |