An Open-Label Single-Arm Prospective Study to Observe Individualized Homeopathic Treatment Outcomes in Women with Chronic Fertility Issues Using Fertility Problem Inventory and Two-Point Discrimination
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Fertility Problem Inventory (FPI) total and subdomain scores from baseline to week 6
研究概览
简要总结
This is a prospective, open-label, single-arm interventional study designed to observe the outcomes of individualized homeopathic treatment in women with chronic fertility issues. The study will include women aged 20–45 years who have been diagnosed with infertility (primary or secondary) for more than 12 months.
Participants will receive individualized homeopathic medicines selected based on classical principles, including totality of symptoms and miasmatic analysis. Remedies will be prescribed in centesimal or LM (Q) potencies according to the physician’s discretion. Treatment will continue for a period of 6 weeks, with follow-ups every two weeks.
Outcome measures will include changes in the Fertility Problem Inventory (FPI), assessing psychosocial stress related to infertility, and Two-Point Discrimination (TPD) scores, evaluating sensory perception possibly related to pelvic or neurological involvement. This multidimensional approach aims to document both emotional and somatosensory changes resulting from individualized homeopathic intervention.
No placebo or control group is involved; each participant serves as her own control through baseline comparison. This study is expected to offer preliminary insights into short-term changes in fertility-related quality of life and neurological perception under homeopathic care.
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
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 20 to 45 years Diagnosed with primary or secondary infertility for above 12 months Regular sexual activity without contraception Willing to provide informed consent.
排除标准
- •Current use of other fertility therapies Structural abnormalities requiring surgical correction Diagnosed endocrine disorders not under control Pregnancy during screening.
结局指标
主要结局
Change in Fertility Problem Inventory (FPI) total and subdomain scores from baseline to week 6
时间窗: baseline to week 6
Domains: Social concern, sexual concern, relationship concern, need for parenthood, and rejection of child-free lifestyle
时间窗: baseline to week 6
次要结局
- Change in Two-Point Discrimination (TPD) threshold from baseline to week 6 at selected dermatomes(baseline to week 6)
研究者
Dr G Senthil Kumaran
Venkateswara Homoeopathic Medical College and Hospital