Evaluation of effectiveness of individualized homoeopathic medicine in the regression of cervical premalignant lesion of women in kanniyakumari district, a single arm clinical interventional study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To explore the effect of individualized Homoeopathic medicines on
研究概览
简要总结
This single-arm interventional study aims to evaluate the effectiveness of individualized Homoeopathic medicines in the regression of cervical premalignant lesions among women in Kanniyakumari district.
The primary objective is to assess whether Homoeopathic medicines have a significant effect on premalignant cervical lesions. Secondary objectives include exploring the specific action of certain Homoeopathic drugs at different stages of cervical intraepithelial neoplasia (CIN) and evaluating the regression of lesion grade and human papillomavirus (HPV) clearance following individualized treatment.
Sexually exposed women aged 21 to 65 years with CIN confirmed by VIA, VILI, colposcopy, liquid-based cytology, and HPV PCR will be enrolled. Women exclusively under Homoeopathic treatment for all complaints will be included. Exclusion criteria include sexually unexposed women, pregnant or puerperal women, those with known HIV infection, or invasive malignancies. Confirmed CIN 2 and CIN 3 cases will undergo detailed Homoeopathic case-taking followed by individualized prescription.
Follow-up assessments will include VIA and VILI every three months and LBC and HPV PCR every six months for twelve months of intervention, with an additional six-month follow-up period. Pre- and post-intervention outcomes will be compared using appropriate statistical methods. A minimum of 100 participants will be enrolled, aiming for 125 to account for attrition.
The study is expected to generate evidence on the Homoeopathic management of cervical premalignant lesions and elucidate stage-specific drug effects on CIN and HPV status.
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
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sexualy active women between the age group of 21years to 65 years Patients with cervical intra-epithelial lesion on LBC.
- •Participants willing to provide informed consent.
排除标准
- •Invasive cancer.
- •HIV positive or immunocompromised.
- •Pregnant/lactating women.
- •Sexually unexposed woman.
结局指标
主要结局
To explore the effect of individualized Homoeopathic medicines on
时间窗: Baseline: At recruitment (before initiation of treatment). | Follow-up 1: At 6 months post-initiation of treatment. | Follow-up 2: At 12 months post-initiation of treatment. | Final evaluation: At 18 months or end of post intervention follow-up period.
premalignant lesions of the cervix.
时间窗: Baseline: At recruitment (before initiation of treatment). | Follow-up 1: At 6 months post-initiation of treatment. | Follow-up 2: At 12 months post-initiation of treatment. | Final evaluation: At 18 months or end of post intervention follow-up period.
次要结局
- 1.To explore specific action of drugs on CIN at different stages.
- 2.To explore regression of lesion grade, and HPV status.(Baseline: At recruitment (before initiation of treatment).)
研究者
Dr Girija L
Dr. L. Girija, Associate Professor, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College