A single-arm pilot clinical study to evaluate the safety and efficacy of a Topical Unani formulation in the management of Cervical Low-Grade Squamous Intraepithelial Lesion (LSIL)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Topical application of the unani formulation is expected to resolve the cytological changes observe in the Pap smear in patients Low-Grade Squamous Intraepithelial Lesion –LSIL
研究概览
简要总结
Women with Low-Grade Squamous Intraepithelial Lesion (LSIL) on Pap smear have a risk of progression to High-Grade Squamous Intraepithelial Lesion (HSIL). Studies report that about 13% of untreated LSIL cases progress to HSIL within 2 years, so close monitoring is essential to prevent cervical carcinoma. In modern medicine, LSIL may be managed by observation, cryotherapy, excision treatment. The Unani system of medicine includes many formulations with anticancer, antioxidant, anti-inflammatory, and wound-healing activities, though clinical studies are limited. Marham-e-Dakhilyun is one such formulation, known for its anti-inflammatory, desiccant, wound-healing, astringent, and antiseptic properties. This clinical study aims to evaluate the efficacy and safety of topical Marham-e-Dakhilyun ointment in women with cervical dysplasia (LSIL). The expected outcome is resolution of cytological changes seen in Pap smear and prevention of progression to cervical cancer.
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Married women Aged 20 to 60 years 2.Patients with clinical signs and symptoms of Cervical Dysplasia including vaginal white discharge, backache, irregular vaginal spotting or postcoital bleeding 3.Confirmed cases of LSIL in Pap smears 4.Willingness to participate in the study and follow the schedule.
排除标准
- •1.Unmarried women 2.Women aged less than 20 and more than 60 years 3.High grade abnormal lesions in Pap smears, HSIL, ASC-H, AGC 4.Associated gynecological pathology like Pelvic inflammatory disease, ovarian tumor, prolapse, polyp.
- •5.Known cases of systemic disease like Diabetes mellitus, hepatorenal, cardiac , pulmonary disorder Immuno-compromised states (HIV/ AIDS) 6.Pregnant and lactating mother 7.Subjects those who are unwilling to come regular follow ups for the entire duration of study.
结局指标
主要结局
Topical application of the unani formulation is expected to resolve the cytological changes observe in the Pap smear in patients Low-Grade Squamous Intraepithelial Lesion –LSIL
时间窗: 8 weeks
次要结局
- 1. To assess the safety and tolerability of topical Unani formulation in patients with Low-Grade Squamous Intraepithelial Lesion (LSIL).(2. To evaluate the potential therapeutic activity of topical Unani formulation in women with LSIL.)
研究者
Dr Syeda Hajra Fatima
National Research Institute of Unani medicine for Skin Disorders