Combined Effect of Myo-Inositol and Folic Acid on Neutrophil to Lymphocyte Ratio and C - Reactive Protein in Patients With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Inflammatory Markers (NLR and CRP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study will be conducted as an open-label trial; therefore, no masking (blinding) will be implemented. Both participants and investigators will be aware of the treatment assignments due to the nature of the interventions, as the medications used (Myo-Inositol and Metformin) differ in formulation and administration, making blinding impractical. Outcome assessors and laboratory personnel analyzing inflammatory markers such as Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP) will not be involved in treatment allocation; however, they will not be formally blinded. Despite the absence of masking, standardized procedures and objective laboratory measurements will be used to minimize bias and ensure the reliability of study results.
入排标准
- 年龄范围
- 25 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS diagnosed women 25-35years and overweight (BMI25 to 29.9 ).
排除标准
- •Ongoing PCOS treatment, major comorbidities e.g. CVD, endocrine disorders, malignancies, pregnancy or diabetes.
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive oral Myo-Inositol in combination with Folic Acid once daily for a duration of three months. Myo-Inositol is a naturally occurring insulin-sensitizing compound that plays an important role in intracellular signaling pathways, particularly those related to insulin and gonadotropin function. It is expected to improve insulin sensitivity, support hormonal balance, and potentially reduce systemic inflammation in women with Polycystic Ovarian Syndrome (PCOS). Folic Acid will be co-administered due to its role in DNA synthesis, methylation processes, and its antioxidant properties, which may contribute to reducing oxidative stress and inflammatory markers.
The primary aim of this intervention is to evaluate its effect on inflammatory biomarkers, specifically the Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP), over a three-month treatment period. Participants will be monitored regularly to assess adherence, clinical respo
干预措施: myo-inositol 2000 gm + folic acid 200 mcg (Dietary Supplement)
Control Group
Participants in the control group will receive oral Metformin in combination with Folic Acid once daily for a duration of three months. Metformin is a well-established insulin-sensitizing agent commonly used in the management of Polycystic Ovarian Syndrome (PCOS). It primarily acts by reducing hepatic gluconeogenesis, improving peripheral insulin sensitivity, and decreasing circulating insulin levels, which may indirectly contribute to the reduction of androgen excess and metabolic dysfunction associated with PCOS.
Folic Acid will be co-administered as a supportive supplement due to its essential role in DNA synthesis, cell division, and homocysteine metabolism. It also possesses antioxidant properties that may help reduce oxidative stress and systemic inflammation.
This control intervention represents the standard pharmacological approach used in PCOS management and will be compared with the Myo-Inositol plus Folic Acid regimen. The primary objective is to assess changes in inflamm
干预措施: myo-inositol 2000 gm + folic acid 200 mcg (Dietary Supplement)
结局指标
主要结局
Change in Inflammatory Markers (NLR and CRP)
时间窗: 3 months
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.
次要结局
未报告次要终点
