Polycystic Ovary Syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age and may be associated with chronic low-grade systemic inflammation. This clinical trial aims to evaluate the combined effect of Myo-Inositol and Folic Acid on systemic inflammatory markers, specifically the Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP), in women with PCOS. The study will compare the effects of Myo-Inositol plus Folic Acid with Metformin plus Folic Acid over a 3-month treatment period. Eligible participants will be randomly assigned to one of the two treatment groups and will take their assigned treatment daily for 3 months. Participants will attend monthly follow-up visits to assess treatment adherence, clinical progress, and any adverse effects. Blood samples will be collected at baseline and after completion of the 3-month intervention to measure NLR and CRP. Participants will also be instructed to record relevant symptoms and report any side effects experienced during the study. The primary purpose of the study is to determine whether Myo-Inositol and Folic Acid reduce NLR and CRP compared with Metformin and Folic Acid in women with PCOS.
Polycystic Ovary Syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age. It is characterised by hyperandrogenism, ovulatory dysfunction, and/or polycystic ovarian morphology, depending on the diagnostic criteria applied. In addition to reproductive and hormonal abnormalities, PCOS is frequently associated with metabolic disturbances, including insulin resistance, obesity, dyslipidaemia, and an increased risk of type 2 diabetes mellitus and cardiovascular disease. Chronic low-grade systemic inflammation has also been increasingly recognised as an important component of PCOS pathophysiology. Women with PCOS may exhibit elevated levels of inflammatory biomarkers, including C-reactive protein (CRP), suggesting the presence of persistent systemic inflammation that may contribute to metabolic and reproductive abnormalities. The Neutrophil-to-Lymphocyte Ratio (NLR) is a simple, inexpensive, and readily available inflammatory marker derived from the complete blood count. It reflects the relative balance between neutrophil-mediated innate immune responses and lymphocyte-mediated adaptive immune responses and has been investigated as a marker of systemic inflammation in several chronic conditions, including PCOS. Similarly, CRP is an acute-phase protein produced primarily by the liver in response to inflammatory stimuli and is widely used as a biomarker of systemic inflammation. Elevated CRP levels have been reported in women with PCOS and may reflect the inflammatory component of the disorder. Assessment of NLR and CRP may therefore provide useful information regarding changes in systemic inflammatory status following treatment. Insulin resistance is a common feature of PCOS and may occur regardless of body mass index. It can result in compensatory hyperinsulinaemia, which may stimulate ovarian androgen production and contribute to impaired follicular development, ovulatory dysfunction, and other clinical manifestations of PCOS. The close relationship between insulin resistance, metabolic dysfunction, and inflammation suggests that interventions aimed at improving insulin sensitivity may also influence inflammatory pathways. Metformin is an established insulin-sensitising medication used in the management of selected women with PCOS. It primarily acts by reducing hepatic glucose production and improving insulin sensitivity. Although Metformin may improve metabolic parameters and has been associated with reductions in some inflammatory markers, gastrointestinal adverse effects such as nausea, diarrhoea, abdominal discomfort, and bloating may occur and can affect treatment adherence in some patients. Myo-Inositol is a naturally occurring compound that participates in intracellular insulin-signalling pathways and has gained attention as a potential therapeutic option for women with PCOS. Through its role in insulin signalling, Myo-Inositol may improve insulin sensitivity and contribute to improvements in ovarian function, hormonal balance, and metabolic parameters. Previous studies have reported potential benefits of Myo-Inositol supplementation in relation to insulin levels, androgen concentrations, menstrual regularity, and ovulatory function in women with PCOS. In addition to these metabolic and reproductive effects, Myo-Inositol may have potential anti-inflammatory properties; however, evidence regarding its effects on systemic inflammatory markers remains limited and requires further investigation. Folic Acid is an essential water-soluble B vitamin that plays an important role in DNA synthesis, cell division, and one-carbon metabolism. It is routinely recommended for women of reproductive age and is particularly important for women who may become pregnant. Folic Acid supplementation has also been investigated in relation to homocysteine metabolism, oxidative stress, and inflammatory processes. The combination of Myo-Inositol and Folic Acid is commonly used in the management of PCOS because of their potentially complementary effects on metabolic and reproductive health. However, the specific effect of this combination on systemic inflammatory markers such as NLR and CRP has not been adequately established. Despite increasing interest in Myo-Inositol as a treatment option for PCOS, limited evidence is available regarding its potential effect on systemic inflammation. Furthermore, comparative evidence assessing Myo-Inositol plus Folic Acid against Metformin plus Folic Acid in relation to inflammatory biomarkers is limited. Therefore, this study aims to investigate the effect of Myo-Inositol and Folic Acid on NLR and CRP in women with PCOS and to compare these effects with those of Metformin and Folic Acid. This study will be conducted as a two-arm randomised controlled trial involving women diagnosed with PCOS according to the Rotterdam criteria. Eligible participants will be women aged 18-35 years who meet the predefined inclusion criteria and are not currently receiving hormonal or insulin-sensitising therapy. Women who are pregnant or breastfeeding, or who have diabetes mellitus, thyroid disorders, or other chronic inflammatory conditions that may independently influence inflammatory markers, will be excluded. Following eligibility assessment and provision of written informed consent, participants will be randomly allocated to either the intervention group receiving Myo-Inositol and Folic Acid or the control group receiving Metformin and Folic Acid. Participants will receive their assigned treatment daily for a period of 3 months and will attend the clinic once every month for follow-up. During each follow-up visit, treatment adherence, clinical progress, symptoms, and any adverse effects will be assessed. Participants will also be instructed to maintain a record of relevant symptoms and to report any side effects or other concerns during the intervention period. Baseline information, including demographic characteristics, body mass index, medical history, and other relevant clinical variables, will be collected before initiation of treatment. Blood samples will be collected at baseline and at the end of the 3-month intervention period. The NLR will be calculated using neutrophil and lymphocyte counts obtained from a complete blood count, while CRP levels will be measured using the specified laboratory method. The primary outcomes of the study will be the changes in NLR and CRP from baseline to the end of the intervention and the comparison of these changes between the two treatment groups. Secondary outcomes may include treatment adherence, changes in relevant clinical symptoms, and treatment tolerability or adverse events. Data will be analysed using appropriate statistical software. Continuous variables will be summarised using measures of central tendency and dispersion, while categorical variables will be presented as frequencies and percentages. Appropriate statistical tests will be selected based on the distribution and characteristics of the data to assess within-group changes and between-group differences. Statistical significance will be considered at a p-value of less than 0.05. The study will be conducted in accordance with applicable ethical and regulatory requirements. Ethical approval will be obtained from the relevant institutional review board or ethics committee before commencement of the study. Written informed consent will be obtained from all participants before enrolment. Participant confidentiality will be maintained throughout the study, and all collected information will be handled in accordance with applicable ethical and institutional requirements. Participants will be informed of their right to withdraw from the study at any time without any consequences to their routine medical care. This study is designed to determine whether treatment with Myo-Inositol and Folic Acid is associated with a greater reduction in NLR and CRP compared with Metformin and Folic Acid over a 3-month period. The findings may provide further evidence regarding the potential role of Myo-Inositol in addressing systemic inflammation associated with PCOS and may contribute to understanding its therapeutic potential as an alternative or complementary treatment approach. However, the relatively short intervention period and sample size may limit the assessment of long-term effects and broader clinical outcomes. This randomised controlled trial will evaluate and compare the effects of Myo-Inositol plus Folic Acid and Metformin plus Folic Acid on systemic inflammatory markers in women with PCOS. By assessing changes in NLR and CRP before and after treatment, the study aims to provide clinically relevant evidence regarding the potential anti-inflammatory effects of Myo-Inositol and its possible role in the management of PCOS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
This study involves two active treatment interventions aimed at evaluating their comparative effects on inflammatory markers in patients with Polycystic Ovarian Syndrome (PCOS). In the intervention arm, participants will receive a combination of Myo-Inositol and Folic Acid administered orally on a daily basis for a duration of three months. Myo-Inositol is selected for its role as an insulin-sensitizing agent that improves intracellular signaling and metabolic function, while Folic Acid is included for its antioxidant properties and potential to reduce homocysteine levels and systemic inflammation. In the control arm, participants will receive Metformin in combination with Folic Acid, also administered orally on a daily basis for three months. Metformin is a well-established insulin-sensitizing drug widely used in the management of PCOS and serves as the standard comparator in this study. Both interventions are intended to improve metabolic and inflammatory status; however, they diff
Peshawar Health Center
Peshawar, Kpk, Pakistan
Change in Inflammatory Markers (NLR and CRP)
This outcome measure will assess the change in inflammatory status of participants by evaluating the Neutrophil-to-Lymphocyte Ratio (NLR) and serum C-reactive protein (CRP) levels from baseline to the end of the 3-month intervention period. NLR will be calculated using values obtained from a complete blood count (CBC), while CRP levels will be measured using standard laboratory biochemical assays. Both markers are widely accepted indicators of systemic inflammation and will be used to determine the effect of Myo-Inositol plus Folic Acid compared to Metformin plus Folic Acid in patients with Polycystic Ovarian Syndrome (PCOS). The difference between baseline and post-treatment values will be analyzed to evaluate the efficacy of the interventions in reducing low-grade chronic inflammation associated with PCOS.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.