The Effect of Combination Therapy Dlbs 3233 and Clomifen Citrate vs Clomifen Citrate on Homa ir, Maturation Follicle, and Menstrual Cycle in PCOS Cases at Muhammadiyah Asri Medical Center Hospital
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in HOMA-IR
研究概览
简要总结
The effect of combination therapy dlbs 3233 and clomifen citrate vs clomifen citrate on homa ir, maturation follicle, and menstrual cycle in PCOS cases at Muhammadiyah Asri Medical Center Hospital
详细描述
to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •married agree to join this research
排除标准
- •dis agree to join research
研究组 & 干预措施
Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta
to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient
The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS
To compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first
干预措施: dlbs 3233 , clomifen citrat (Combination Product)
结局指标
主要结局
Change in HOMA-IR
时间窗: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
HOMA-IR will be used to assess insulin resistance. Fasting glucose and fasting insulin will be collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment, and HOMA-IR will be calculated as a single index value.
Change in serum AMH concentration
时间窗: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
Serum anti-mullerian hormone (AMH) will be measured from venous blood collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment to assess ovarian function response.
次要结局
- Change in total follicle count on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Change in number of mature follicles on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Change in mature follicle diameter on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Menstrual cycle regularity during the 3-month treatment period(During the 3-month treatment period)