| CTRI Number |
CTRI/2023/08/055997 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| 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
|
|
|
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= 2 |
| Name of Committee |
Approval Status |
| IEC ,SKIMS |
Approved |
| IEC,SKIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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)= "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)
|
12/08/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is a randomized, double-blind, parallel Group, multicentric trial comparing the safety and efficacy of Ovydose @ 400mg plus Metformin 1000mg versus Metformin 1000mg alone for 12 months in total of 200 patients (100 patients in each group) with PCOS. The study will be conducted at two centers (SKIMS and JVC). The primary outcome measures will include Clinical endpoints while the Secondary outcome measures will include biochemical and hormonal endpoints which will be recorded at 0 months,4th month, 6th month, 8th month, and 12th month of the trial. |