A Prospective Comparative Evaluation Of The Effect Of Folliculinum Vs Constitutional Homoeopathic Medicine In Cases Of PCOS, Assessed By The FSH/LH Ratio
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in serum FSH/LH ratio from baseline to 12 months (or end of treatment), measured in a certified laboratory.
研究概览
简要总结
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder in women of reproductive age, often associated with menstrual irregularities, hyperandrogenism, and altered FSH/LH ratio. This prospective, randomized, comparative study aims to evaluate the effect of Folliculinum versus individualized constitutional homeopathic medicines on hormonal balance in women with PCOS. A total of 50 female patients, aged 18–40 years, diagnosed according to Rotterdam criteria and not on hormonal treatment for at least 3 months, will be enrolled. Participants will be randomly allocated into two groups: one receiving Folliculinum and the other receiving the individualized constitutional remedy, both for 12 months. The primary outcome is the change in serum FSH/LH ratio from baseline to 12 months. Secondary outcomes include menstrual regularity, hirsutism (Ferriman-Gallwey score), acne severity (GAG score), emotional health (DASS-21), and BMI. Follow-up assessments will occur every 3 months. This study will provide objective evidence on the comparative efficacy of Folliculinum versus constitutional homeopathy in managing PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Female patients aged 18 to 40 years Suffering from PCOS for a minimum duration of 6 months and not more than 5 years Diagnosed with PCOD based on Rotterdam criteria (at least 2 of 3: menstrual irregularity, clinical/biochemical hyperandrogenism, polycystic ovaries on ultrasound) Not on hormonal treatment for at least 3 months prior Willing to follow up for 6 months Able to understand and communicate in Hindi, Gujarati, English for proper follow-up and questionnaire completion Able to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Change in serum FSH/LH ratio from baseline to 12 months (or end of treatment), measured in a certified laboratory.
时间窗: 12 month
次要结局
- 1. Menstrual Regularity: Improvement in cycle pattern assessed using Menstrual Regularity Score (MRS) over the 12-month study period.(2. Hirsutism: Change in severity assessed by the Ferriman-Gallwey score.)
研究者
Vataliya Mansi Mukeshbhai
Rajkot Homoeopathic Medical College
