Effect of Remote Ischemic Pre-conditioning (RIPC) on Endothelial Dysfunction in Women with Polycystic Ovary Syndrome(PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- maximum percentage increase in flow after cuff deflation compared to baseline flow
研究概览
简要总结
We are conducting an explorative, randomized, double- blinded, SHAM- controlled trial at the outpatient clinic at the department of Gynaecology in collaboration with the Departments of Cardiology, Endocrinology and Radiology at IMS, BHU, Varanasi.
We will include 50 pre- menopausal women with classical PCOS fulfilling the inclusion and exclusion criteria as described earlier.
The patients will be randomly assigned 1:1 to RIPC (Remote Ischemic Pre- Conditioning) or SHAM group using block method once daily for 7 days . Outcome variables as described will be measured at baseline and RIPC.
The intervention group will recieve a RIPC protocol of 4 cycles of 5 minutes each with occlusion to 220 mmHg with standard sphymomanometer BP cuff on the right arm followed by 5 minutes re-perfusion . One intervention of 4 cycles amounting to 35 minutes will be performed daily for 7 days.
The SHAM procedure will consist of a pressure cuff , inflated on the right upper arm for the same periods as the RIPC intervention but only to 40 mmHg as it has shown to mimic occlusion but not limiting blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Case known of classical PCOS.
排除标准
- •Thyroid dysfunction Cushing syndrome Late onset of congenital adrenal hyperplasia Pregnancy and breastfeeding Use of glucocorticoids, OCPs, ovulatory agents within 3 months of study Smoking, drug and alcohol abuse.
结局指标
主要结局
maximum percentage increase in flow after cuff deflation compared to baseline flow
时间窗: 4 cycles of 5 minutes each with occlusion to 220 mmHg followed by 5 min re- perfusion | another intervention of 4 cycles of 35 minutes daily for 7 days
次要结局
未报告次要终点