Myoinositol a new treatment option in Polycystic Ovarian Syndrome versus metformin-the conventional drug.

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2019/09/021403
• Lead Sponsor: Swati Jain

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-09-24
• Study Start: 2019-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• •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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•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 Measures

Name	Time	Method
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 .

Trial Locations

Locations (1)

Teerthanker Mahaveer Medical College; 🇮🇳 Moradabad, UTTAR PRADESH, India

Teerthanker Mahaveer Medical College

🇮🇳Moradabad, UTTAR PRADESH, India

Dr Rehana Najam

Principal investigator

9837291920

rehananajam01@gmail.com