A pilot study on clinical evaluation of siddha herbal formulation Iluppai Ennai( External Medicine) in the management of Kaduvan(Lichen Planus) among out-patients attending the OPD of ayodhidass pandithar hospital, National Institute of siddha.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in LICHEN PLANUS SEVERITY INDEX Score will be assessed before and after treatment period.
研究概览
简要总结
Background:
Lichen planus (LP) is an inflammatory disorder of the skin and mucous membranes with no known cause. It appears as pruritic, violaceous papules and plaques most commonly found on the wrists, lower back, and ankles. A lattice-like network of white lines called Wickham striae overlies the lesions but is most easily observed on the buccal mucosa where erosions can also be present. It can display a variety of lesion types, but the most common presentation is an area of polygon-shaped, itchy, violaceous, flat-topped papules a few millimeters wide. This classic presentation is known as The Six Ps of LP: purple, polygonal, planar, pruritic papules, and plaques.
OBJECTIVE:
• To evaluate the therapeutic effectiveness of the external medicine “ILUPPAI ENNAI” in the management of KADUVAN (LICHEN PLANUS) through LPSI SCORE(3).
• LPSI score is expected to change from moderate to mild or nil and mild to nil after treatment
STUDY DESIGN : An open clinical trial – Single arm.
EXPECTED OUTCOME:
Changes in LICHEN PLANUS SEVERITY INDEX will be assessed before and after treatment.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age: 30 to 60 years Gender: Male/Female/Transgender Patients having the signs and symptoms of kaduvan (lichen planus) and LPSI score below 53 Purple polygonal planar pruritic papules plaques.
- •Patients willing and able to provide informed consent and to comply with the study protocol.
排除标准
- •Pregnant or lactating women.
- •Known cases of Skin diseases [contact dermatitis, vitiligo, psoriasis, atopic dermatitis].
- •Other diseases or medications that might directly interfere in the study.
结局指标
主要结局
Reduction in LICHEN PLANUS SEVERITY INDEX Score will be assessed before and after treatment period.
时间窗: 2 months - Screening | 2 months - Patient enrollment | 2 months - outcome assessment
次要结局
未报告次要终点
研究者
Suruthi Balakrishnan
National Institute of Siddha