Effect of Shakti Bandha Asana on Continuous Glucose Monitoring Among Patients with Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time in range (TIR)
研究概览
简要总结
Polycystic Ovarian Syndrome (PCOS) is a common endocrine disorder in reproductive-age women, marked by irregular menstrual cycles, hyperandrogenism, and polycystic ovaries. It is associated with metabolic dysfunction, particularly insulin resistance, hyperinsulinemia, and impaired glucose metabolism. Insulin resistance is central to PCOS pathology, leading to increased androgen production, worsening symptoms like hirsutism, acne, and anovulation. Traditional blood glucose monitoring, including fasting blood glucose (FBG) and hemoglobin A1c (HbA1c), offers limited insights, giving only a snapshot of glucose levels. In PCOS, glucose levels can fluctuate due to hormonal imbalances, stress, and diet. Continuous Glucose Monitoring (CGM) allows real-time glucose tracking, providing a thorough assessment of glycemic patterns and insulin sensitivity. CGM measures Time in Range (TIR), glycemic variability (GV), and mean glucose levels, enabling detailed evaluation of metabolic status. It is effective for assessing lifestyle interventions on glucose regulation in PCOS patients. Yoga is recognized for its benefits on metabolic and hormonal disorders, including PCOS. Shakti Bandha Asanas (Energy Locking Postures) stimulate endocrine glands, improve circulation, and enhance metabolic function. These asanas promote hormonal balance and improve insulin sensitivity. The gentle stretching, controlled breathing, and relaxation techniques in these postures positively influence glucose metabolism and overall metabolic health in PCOS patients. This study aims to evaluate their effects on real-time glucose fluctuations in PCOS patients using CGM. This randomized controlled trial (RCT) investigates whether Shakti Bandha Asanas can improve glycemic control in PCOS patients. CGM data is expected to show increased TIR and reduced blood glucose fluctuations, indicating better metabolic control. Secondary benefits may include improved menstrual regularity, reduced insulin resistance, and enhanced stress management. PCOS is a multifaceted disorder requiring holistic management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 21.00 Year(s)(—)
- 性别
- Female
入选标准
- •At least two-thirds of the features listed in the Rotterdam criteria for PCOS, Oligomenorrhea or Amenorrhea, Clinical Hyperandrogenism (Ferriman–Gallwey scale).
排除标准
- •Patients reported adverse events in patch test Hormonal treatment or used oral contraceptives Thyroid abnormalities A prior experience of yoga.
结局指标
主要结局
Time in range (TIR)
时间窗: Assessment will be evaluated the day before and the day after the intervention.
HbA1c
时间窗: Assessment will be evaluated the day before and the day after the intervention.
次要结局
- Total Cholesterol(HDL(High Density Lipoprotein))
研究者
A Keerthana
International Institute of Yoga and Naturopathy Medical Sciences
