Effectiveness of Individualized Homoeopathic Treatment in the Management of Cutaneous Lichen Planus- A Prospective Single-Arm Clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in the extent and intensity of lesions as per LPSI score.
研究概览
简要总结
This prospective, open-label, single-arm clinical study is designed to evaluate the effectiveness of individualized homoeopathic treatment in the management of cutaneous lichen planus. The trial will be conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi, with a total of 40 patients aged 18–70 years, diagnosed with cutaneous lichen planus (excluding mucosal involvement), recruited from the outpatient department. Each participant will undergo detailed case-taking, repertorization, and individualized prescription of homoeopathic medicines, administered orally, with dosage and repetition based on symptom severity and patient susceptibility. The duration of the study is 12 months, comprising 6 months of enrollment and 6 months of follow-up. Effectiveness will be assessed primarily through the reduction in disease severity measured by the Lichen Planus Severity Index (LPSI) score, and secondarily by improvement in patient quality of life measured by the Dermatology Life Quality Index (DLQI). Statistical analysis will be performed with significance set at p less than 0.05. Institutional Ethical Committee clearance and CTRI registration will be obtained, informed consent will be taken from all participants, and patient confidentiality and safety will be strictly maintained.
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients with signs and symptoms of cutaneous Lichen Planus.
- •2.Age between 18-70 years.
- •3.Patients willing to give written informed consent.
- •4.Both genders.
排除标准
- •1.Patients who tested positive for the Hepatitis C Virus antibody test.
- •2.Pregnant and lactating women.
- •3.Patient with advanced systemic illness.
- •4.Patient with any psychiatric illness.
- •5.Patients with mucosal involvement (oral, genital, anal).
- •6.Immunocompromised individuals.
- •7.Patient of drug abuse.
结局指标
主要结局
Reduction in the extent and intensity of lesions as per LPSI score.
时间窗: At baseline and at 24 weeks
次要结局
- Improvement in quality of life measured by DLQI.(At baseline & at 24 weeks)
研究者
Dr Kago Dolya
Nehru Homoeopathic Medical College and Hospital
