| CTRI Number |
CTRI/2019/09/021403 [Registered on: 25/09/2019] Trial Registered Prospectively |
| Last Modified On: |
24/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Myoinositol a new treatment option in Polycystic Ovarian Syndrome versus metformin-the conventional drug. |
|
Scientific Title of Study
|
Comparative Study of Metformin versus Myoinositol in Polycystic Ovarian Syndrome patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Jain |
| Designation |
Post Graduate Student |
| Affiliation |
Teerthanker Mahaveer Medical College |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College, NH-24 Delhi Road, Moradabad
NH-24, Delhi Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9039140065 |
| Fax |
|
| Email |
swatijain3994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rehana Najam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College, NH-24 Delhi Road
NH-24 Delhi Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837291920 |
| Fax |
|
| Email |
rehananajam01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rehana Najam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College, NH-24 Delhi Road
NH-24 Delhi Road
UTTAR PRADESH
244001
India |
| Phone |
9837291920 |
| Fax |
|
| Email |
rehananajam01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swati Jain |
| Address |
Teerthanker Mahaveer Medical College, NH-24 Delhi Road, Moradabad Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Rehana Najam |
Teerthanker Mahaveer Medical College |
NH-24 Delhi Road
Moradabad
UTTAR PRADESH |
9837291920
rehananajam01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMMCRC Institutional 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 |
METFORMIN |
Metformin is an oral biguanide,and first insulin sensetising drug to be used in pcos,it modulated endothelin function causes weight loss and improves ovarian function and reduces androgen levels also.In my study metformin will be given 500mg twice daily for 6 months.follow up will be done at 3rd and 6th monthly. |
| Comparator Agent |
MYOINOSITOL |
Insulin sensotising agent.Inositol phosphoglycans activate enzymes that control glucose metabolism .Any defect in IPG can cause impaired insulin metabolism which leads to PCOS.In our study myoinositol will be given 1 gm once daily for 6 months ,after that monthly follow up of patients will be done in terms of clinical improvements and 3rd and 6th monthly follow up will be done. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
•All the females of age group 15-40 years fulfilling the Rotterdam’s criteria.3
•According to Rotterdam’s Criteria the affected must have :(atleast 2 out of 3)
(A) Oligovulation and /or anovulation .
(B)Hyperandrogenism(clinical/or biochemical) .
(C)Polycystic-ovaries,identified sonographically.
|
|
| ExclusionCriteria |
| Details |
1.Patients already on other drug treatment for PCOS (like oral contraceptive pills)
2.Deranged kidney or liver function tests
3. Thyroid disorders
4.Known hypersensitivity to drugs
5. Galactorrhoea
6. Patient on any infertility treatment/fertility enhancing drugs
7. Established cases of diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To compare the EFFECTIVENESS of Metformin versus Myoinositol in Polycystic ovarian syndrome patients in terms of weight reduction, Ferriman Gallwey score, menstrual cycle pattern after 3 months. After 6 months, complete radiological, biochemical and anthropometric reassessment will be done. |
Follow up will be done at 3rd and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify patients of PCOS patients by Rotterdam’s criteria.
2.To study the role of Metformin in PCOS patients in terms of clinical improvement ,biochemical correction and radiological parameters .
3.To study the role of Myoinositol in PCOS patients in terms of clinical improvement,biochemical correction and radiological parameters.
4.Comparing Metformin versus Myoinositol in terms of clinical ,biochemical and radiological correction along with side effects.
|
Follow up will be done at 3rd and 6th month |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
30/09/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- Patients attending the gynaecology OPD with clinical features suggestive of PCOS (menstrual abnormalities, obesity, acne, hirsuitism, acanthosis nigrans) will be selected after detailed history and clinical examination.
- Anthropometric examination will be done in terms of weight, height , WHR, BMI.
- They will further be subjected to biochemical investigations and ultrasonography to confirm diagnosis.
- Subjects who are eligible according to inclusion criteria will be enrolled in the study after written and informed consent.
- The patients will be randomised by envelope method.
- There will be 2 groups, one group will be getting Metformin 500mg (Me)trice daily and the other group will be getting Myoinositol 1 gram (My) twice daily.
- Monthly follow up will be there in terms of compliance, clinical improvement.
- Every 3 monthly, there will be a follow up in terms of biochemical improvement as well as clinical.
- After 6 months, patients will be investigated completely and accroding to our objectives, clinical biochemical radiological features and side effects will be assessed.
|