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CTRI Number  CTRI/2023/08/055997 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 23/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to compare how well Ovydose® combined with Metformin works compared to Metformin alone for treating Polycystic Ovary Syndrome (PCOS). 
Scientific Title of Study   A phase III controlled clinical trial comparing efficacy of Ovydose® plus Metformin versus Metformin alone in management of Polycystic Ovary Syndrome (PCOS).  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Mohammad Ashraf Ganie 
Designation  Professor  
Affiliation  Sher-i-kashmir institute of medical sciences 
Address  Ward 1p Room No 117 Sher-i-kashmir institute of Medical Sciences(SKIMS),Soura
nil
Srinagar
JAMMU & KASHMIR
190011
India 
Phone  9419041546  
Fax    
Email  ashraf.endo@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohammad Ashraf Ganie 
Designation  Professor  
Affiliation  Sher-i-kashmir institute of medical sciences 
Address  Ward 1p Room No 117 Sher-i-kashmir institute of Medical Sciences(SKIMS),Soura
nil
Srinagar
JAMMU & KASHMIR
190011
India 
Phone  9419041546  
Fax    
Email  ashraf.endo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Syed Douhath Yousuf 
Designation  Scientist 
Affiliation  Sher-i-kashmir institute of medical sciences,Soura 
Address  OPD block Room No 125 PCOS Clinic Sher-i-kashmir institute of Medical Sciences(SKIMS),Soura
nil
Srinagar
JAMMU & KASHMIR
190011
India 
Phone  9906449673  
Fax    
Email  syeddouhath@gmail.com  
 
Source of Monetary or Material Support  
Immunity Bloom ,Health Divison, Saveer Biotech Limited D-54, Site IV, Surajpur industrial area, UPSIDC, Greater Noida, Uttar Pradesh, 201306 
 
Primary Sponsor  
Name  Immunity Bloom ,Health Divison, Saveer Biotech Limited. 
Address  D-54, Site IV, Surajpur industrial area, UPSIDC, Greater Noida, Uttar Pradesh, 201306 
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Mohammad Ashraf Ganie  Sher-i kashmir institute of medical sciences,Soura  Department of Endocrinology, Sher-i kashmir institute of medical sciences, Soura, J&K, India.
Srinagar
JAMMU & KASHMIR 		 9419041546

ashraf.endo@gmail.com 
Dr Syed Naseer  SKIMS Medical college, [Jehlum valley medical College(JVC)]  Department of Obstetrics and Genecology. Ward Block, Second Floor.
Srinagar
JAMMU & KASHMIR 		 8491940082

drsyednaseer1974@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC ,SKIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metformin  1000 mg/Once a day/Oral administration/1 year 
Intervention  Ovydose plus Metformin  400mg Ovydose@ /1000 mg Metformin/ once a day/oral administration/ 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. The study will include PCOS women aged 18-45 years who had a confirmed diagnosis of PCOS based on the Rotterdam 2003 criteria.
2. Participants with a body mass index (BMI) ranging from 25 to 30 kg/m² will be included in the study.
3. PCOS Women with no history of type 2 diabetes mellitus, liver or kidney disease, or other severe illnesses will be eligible for participation.
4. The study will exclude PCOS women who were using oral contraceptives or other medications that could impact insulin resistance and/or menstrual irregularities. 
 
ExclusionCriteria 
Details  1. PCOS Women with history of Type 2 DM (diabetes mellitus) will be excluded from the study.
2. Pregnant PCOS women will be excluded from participation in the study
3. PCOS Women with infections, immunological diseases, malignancies, and other hormonal disorders such as deranged PRL (prolactin), TSH (thyroid-stimulating hormone), and 17-OHP (17-hydroxyprogesterone) will be excluded from the study.
4.PCOS Women with known cardiac or peripheral vascular diseases will be excluded from the study.
5.PCOS Women who were on insulin therapy will be exempted from participation in the study.
6. PCOS Women with impaired hepatic or renal function will be excluded from the study.
7. Those PCOS women who were taking ginseng or other herbs for diabetes will be excluded from the study.
8. Participants who were already involved in any other investigational drug studies will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

Clinical Endpoint
1. Menstrual irregularities
2. No of cycles per year
3. Blood Pressure.
4. Hirsutism (FG score)
5. Acne will be evaluated using a standardized scoring system. 		 0 month
Fourth month
Sixth month
Eighth month
Twelfth month  
 
Secondary Outcome  
Outcome  TimePoints 
Hormonal Endpoint
1. The levels of SHBG, LH, FSH, testosterone, estradiol, & prolactin will be measured at baseline and at 12 months.
2. Insulin resistance: HOMA-IR index will be calculated.

Biochemical Endpoints
1. Glucose intolerance
2. HBA1C
3. Lipid levels will be evaluated.


Inflammatory Factors
1. IL-6 2.TNF-α

Safety Indicators
LFT & KFT
 		 0 month
Fourth month
Sixth month
Eighth month
Twelfth month  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/08/2023 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Paper awaited 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This randomized, double-blind, placebo-controlled trial was conducted at SKIMS-Soura and JVC, Srinagar (September 2023–December 2025). A total of 240 women with PCOS were randomized into two groups: Ovydose® + metformin (Green arm) and placebo + metformin (Red arm). Clinical, biochemical, hormonal, radiological, and inflammatory parameters were assessed at baseline and 12 months, with continuous safety monitoring.

Out of 240 participants, 144 completed the study. 71 completed in green arm and 73 completed in red arm. Both groups showed improvement; however, the Ovydose® group demonstrated significantly greater benefits, including improved menstrual cyclicity (8 to 11 cycles/year; p=0.01), and greater reductions in weight, BMI, waist circumference, insulin resistance (HOMA-IR), and testosterone (p=0.01). Additional improvements were observed in lipid profile, ovarian morphology, acne, and hirsutism. Inflammatory markers and psychiatric symptoms (anxiety and depression) also declined more in the Ovydose® group. Notably, 4 out of 7 married women in this group conceived during the study.The treatment was well tolerated with no major adverse events.

Ovydose® plus metformin provides superior improvements in metabolic, hormonal, inflammatory, reproductive, and psychological outcomes in PCOS compared to metformin alone, and is safe for long-term use as an effective adjunct therapy.


 
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