Randomized Controlled Clinical Trial to evaluate the efficacy of Siddharthak Gel over Siddharthak Lepa in the management of Dadrukushtha (Tinea Corporis)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Global Assessment Score (GAS) based on the evaluation of six signs and symptoms of Dadrukushtha (Tinea Corporis):
研究概览
简要总结
The present study is a randomized, controlled, open label clinical trial designed to evaluate and compare the efficacy of Siddharthak Gel and Siddharthak Lepa in the management of Dadrukushtha Tinea Corporis. Eighty patients diagnosed with Dadrukushtha aged between 20 and 50 years will be randomly allocated into two groups. The Siddharthak Gel group will receive topical application of a gel based Siddharthak formulation while the Siddharthak Lepa group will receive a traditional Lepa application. Primary outcome measures include the assessment of Kandu itching, Raga redness, Visarpana spreading, Tamra varna coppery discoloration, Pidaka papules, and Mandala lesion characteristics using Global Assessment Scoring GAS. Secondary outcomes include changes in the Dermatology Life Quality Index DLQI and monitoring of adverse events. The study hypothesis is that Siddharthak Gel offers superior or equivalent clinical outcomes with better patient compliance compared to traditional Siddharthak Lepa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •20 to 50 years age of group participants irrespective of Gender Religion Socio-economic and Marital Status suffering from dadrukushtha (Tinea corporis) 2) Participant assessed and diagnosed thoroughly based on Ayurvedic classical signs & symptoms of dadrukushtha 3) Participant having multiple lesions of dadrukushtha on body.
排除标准
- •Known participant with history of other systemic disorders like diabetes mellitus HIV Tuberculosis etc 2) Participant’s receiving prolonged immunosuppressant and antibiotic therapy 3) Known participant having history of Chronic and severe cases associated with complications or secondary infection 4) Treated case & those who were received topical antifungal treatment within 1 week before baseline visit 5) Participant Currently receiving anti-fungal treatments like systemic or local 6) Participant suffering from other skin diseases than dadru like psoriasis, herpes etc.
结局指标
主要结局
Global Assessment Score (GAS) based on the evaluation of six signs and symptoms of Dadrukushtha (Tinea Corporis):
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Kandu (itching)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Raga (redness)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Visarpana (spreading of lesion)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Tamra Varna (coppery discoloration)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Pidaka (papular eruptions)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Mandala (number and size of circular lesions)
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
Each parameter will be assessed using a 0–3 severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
The total GAS will be calculated by summing the scores of all parameters (Range: 0–18).
时间窗: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
次要结局
- DLQI (Dermatology Life Quality Index) Score(Day 0, Day 15)
研究者
Dr Ajit Vijaykumar Patil
Tilak Ayurved Mahavidyalaya Pune