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临床试验/CTRI/2020/01/022952
CTRI/2020/01/022952已完成1 期

PHYTOESTROGEN RICH SUPPLEMENTATION ON MENSTRUAL IRREGULARITIES, PSYCHOLOGICAL STRESS AND PHYSICAL ACTIVITY LEVELS IN WOMEN WITH PCOS

Founder Chancellor shri NPV Ramasamy udayar research fellowship1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月27日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
improvement in ovulation, decrease in blood glucose level and weight, reduced stress level

研究概览

简要总结

The present study employeda unique approach by combining the phytoestrogen-rich ingredients and developedthe phytoestrogen-rich supplement. Its potential impact among women with PCOSwas analyzed. Results showed apotential decrease in depression, anxiety, and stress levels among the PCOSsubjects. It accentuates that providing appropriate dietary counseling could havea potential impact in reducing LDL, free cholesterol, depression, anxiety, andstress levels in individuals with PCOS. It also reported an increase in HDL, FSH levels and improved the regulation of menstrualcycles among the subjects in the intervention group. Overall the studyemphasized the statement that omega-3-fatty acid, polyphenols and flavonoidscontent in the phytoestrogen rich supplement had a positive impact in themanagement of PCOS. This highlights the need for longer-term studies to explorethe extended benefits of the interventions and lifestyle changes proposed inthe study

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • pre menopausal and reproductive aged women 18-45 years, patients willing to give inform consent.

排除标准

  • women with hysterectomy, cushing syndrome, hypo gonadisam and thyroid dysfunction.

结局指标

主要结局

improvement in ovulation, decrease in blood glucose level and weight, reduced stress level

时间窗: The Primary outcome will be measured after two months of supplementation period. The expected outcomes are improvement in ovulation, decrease in blood glucose level and weight, reduced stress level

次要结局

  • Reduced oxidative stress and reduced facial hair growth(reduction in oxidative stress)

研究者

发起方
Founder Chancellor shri NPV Ramasamy udayar research fellowship
申办方类型
Research institution and hospital

研究点 (1)

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