An Open Randomised Comparative Clinical Study of Shrungaveradi Lepa and Edgajadi Lepa in the Management of Dadru Kushtha with Special Reference to Tinea Corporis.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Kandu – Itching
研究概览
简要总结
The primary purpose of this open randomizedcomparative clinical study is to evaluate and compare the efficacy ofShrungaveradi Lepa and Edgajadi Lepa in the management of Dadru Kushtha - TineaCorporis, a superficial fungal infection of the skin characterized by itching-kandu, redness -raga, eruptions - pidaka, and raised patches -udgat mandala.According to Ayurveda, Dadru is classified under Kushtha and is associated withKapha and Pitta dosha imbalances, affecting the skin, blood, muscle, and lymphtissues. In contemporary understanding, Tinea Corporis is a dermatophyteinfection commonly affecting adults, especially those exposed to warm, moistconditions. The study involves a total of 72 patients, divided equally into twogroups 36 each, with a treatment duration of 21 days. Each formulation isapplied locally at a dose of 200 mg per square cm twice daily. The primaryhypothesis states that both Shrungaveradi Lepa and Edgajadi Lepa are equallyeffective, however secondary hypotheses explore whether one may be superior.The study aims to scientifically validate the traditional Ayurvedic topicaltherapy, offering a potential evidence-based alternative for managingsuperficial fungal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 18 to 60 years Sex All genders Patient with signs and symptoms of Dadru Kushtha Tinea corporis like Kandu Raga Pidaka and udgat mandala Patient understanding and willing to sign the informed consent form Area of largest lesion 25cm square.
排除标准
- •Patient having skin lesions other than Dadru kushtha Tinea corporis like Eczema psoriasis and urticaria Pregnancy and lactating mother Known case of AIDS HIV Positive and Hepatitis B.
结局指标
主要结局
Kandu – Itching
时间窗: Three weeks
Daha - burning
时间窗: Three weeks
Pidaka – papule
时间窗: Three weeks
Size and Number of Lesions in specific areas of the body.
时间窗: Three weeks
Raga - Erythema
时间窗: Three weeks
次要结局
未报告次要终点
