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临床试验/CTRI/2025/10/095531
CTRI/2025/10/095531尚未招募4 期

A Prospective Comparative Evaluation Of The Effect Of Folliculinum Vs Constitutional Homoeopathic Medicine In Cases Of PCOS, Assessed By The FSH/LH Ratio

Sainath Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月15日最近更新:

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

发起方
Sainath Hospital
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Vataliya Mansi Mukeshbhai

Rajkot Homoeopathic Medical College

研究点 (1)

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