A Comparative Open-Label, Double-Arm, Clinical trial to study the combined efficacy of Arka Kshara with Nimbadi Guggulu and Apamarga Kshara with Nimbadi Guggulu in the management of Karnini Yoni Vyapad (Cervical Erosion)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete healing of cervical erosion on speculum examination.
研究概览
简要总结
This study is designed as a comparative clinical trial to evaluate the efficacy of Arka Kshara against the established standard, Apamarga Kshara, in the management of Karnini Yoni Vyapad, which correlates clinically with Cervical Erosion (Cervical Ectopy). The research focuses on the therapeutic potential of Kshara Karma—utilizing the Dahana, Pachana, and Lekhana properties of these alkaline preparations—to facilitate the removal of abnormal columnar epithelium and promote the regeneration of healthy squamous epithelial layers. While Apamarga Kshara serves as the traditional gold standard, this study seeks to validate Arka Kshara (derived from Calotropis gigantea) as a novel alternative that may offer superior anti-inflammatory and wound-healing benefits with minimal local tissue damage.
To ensure standardized internal support and systemic detoxification, both treatment groups will receive Nimbadi Guggulu as an adjuvant. This combination is intended to provide Krimighna (antimicrobial) and Shothahara (anti-inflammatory) effects, thereby reducing the risk of infection and enhancing the Ropana (healing) process. Clinical outcomes will be measured by the reduction of symptoms such as excessive vaginal discharge, post-coital bleeding, and backache, alongside the visual observation of cervical tissue repair. Ultimately, the study aims to establish a safe, effective, and minimally invasive Ayurvedic protocol for women of reproductive age suffering from this common gynecological condition.
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 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •1 Sexually active women and clinically diagnosed and confirmed subjects of cervical erosion of 21-45 years of age and fulfilling the diagnostic criteria.
- •2 Participants who are ready to participate and have signed for informed consent form.
排除标准
- •1 Known case of cervical carcinoma, uterine prolapse 2 Known case of coagulation disorders 3 Participants with HIV, VDRL, HBsAg positive 4 Participants on oral contraceptive pills, those using Intra uterine Contraceptive devices 5 Participants with diagnosed case of CIN (Cervical intraepithelial neoplasia).
结局指标
主要结局
Complete healing of cervical erosion on speculum examination.
时间窗: 15 days
次要结局
- Reduction in vaginal discharge
研究者
Dr Sneha Shetkar
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
