Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Study Overview
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Brief Summary
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PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.

Official Title
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Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle

Conditions
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PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Intervention / Treatment
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* Drug: Metformin Hydrochloride
* Drug: MI/DCI combination in 40:1 ratio
* Drug: Combination of Metformin hydrochloride and MI/DCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age; Residence; level of education & type of work; Marital and fertility statuses, and if infertility was the main complaint; Presence of risk factors as sedentary lifestyle; Emotional stress and family history of PCOS; Obesity-related medical disorders especially DM or MAFLD; History of previous treatment for PCOS and its outcomes; Menstrual pattern such as infrequent menstrual periods. Exclusion Criteria: Women had other manifestations of metabolic syndrome: Cardiac manifestations of PCOS; Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS; Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications; Had morbid obesity with body mass index (BMI) >35 kg/m2; Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Met Group<br> | Drug: Metformin Hydrochloride<br>* Met Group Received metformin hydrochloride 500 mg tab 3 times Daily<br>|
| Active Comparator: MI Group<br> | Drug: MI/DCI combination in 40:1 ratio<br>* MI-group received MI/DCI combination in 40:1 ratio twice daily<br>|
| Active Comparator: MM Group<br> | Drug: Combination of Metformin hydrochloride and MI/DCI<br>* MM Group Received both Met and MI Groups Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of mensural pattern | The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women | 6 months |