Effectiveness of Folliculinum in regulating Menstrual cycles in women with PCOS a single arm prospective clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The objective is to measure the percentage of participants who develop a regular menstrual pattern after six months of Folliculinum
研究概览
简要总结
Role of Folliculinum in managing the irregular menstrual cycles in women with PCOS Total 36 women will be enrolled PCOS Questionnaire and USG will be assessed at baseline and end and Man Whitney U test will be assessed at baseline and 6 month
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 18–40 years PCOS diagnosed by Rotterdam 2023 criteria At least two of the following oligo/amenorrhea Clinical or biochemical hyperandrogenism Polycystic ovarian morphology Cycle length more than 35 days Or less than 21 days Or amenorrhea.
排除标准
- •Current pregnancy or lactation Ovarian malignancy Uterine malignancy Active pelvic inflammatory disease Severe hepatic impairment Severe renal impairment eGFR less than or equal to 30 mL per minute AST or ALT more than three times normal Participation in another interventional study within 30 days Uncontrolled diabetes with HbA1c more than 8.5 percent Well controlled type 2 diabetes on diet is allowed Well controlled type 2 diabetes after 4 week washout from metformin is allowed Major psychiatric illness requiring hospitalization in past 6 months Stable depression or anxiety on unchanged medication for at least 3 months is allowed.
结局指标
主要结局
The objective is to measure the percentage of participants who develop a regular menstrual pattern after six months of Folliculinum
时间窗: Total 16 months | Enrollment period 6 months | Follow up 6 months | Data Analysis 2 months | Report writing 2 months | PCOS Questionnaire at baseline and end
A regular cycle is defined as 21 to 35 days with bleeding lasting no longer than seven days
时间窗: Total 16 months | Enrollment period 6 months | Follow up 6 months | Data Analysis 2 months | Report writing 2 months | PCOS Questionnaire at baseline and end
Another objective is to assess changes in cycle related quality of life as reported by participants
时间窗: Total 16 months | Enrollment period 6 months | Follow up 6 months | Data Analysis 2 months | Report writing 2 months | PCOS Questionnaire at baseline and end
This will be measured using a validated PCOS specific questionnaire
时间窗: Total 16 months | Enrollment period 6 months | Follow up 6 months | Data Analysis 2 months | Report writing 2 months | PCOS Questionnaire at baseline and end
次要结局
- To track and compare pre and post treatment ultrasound findings(The focus is on ovarian structure and on average ovarian volume and also on antral follicle count)
研究者
Dr Shrishti
Bakson Homoeopathic Medical College and Hospital