Pharmaco-therapeutic Evaluation of Different Parts (Leaf, Stem Bark, and Root Bark) of Shami (Prosopis cineraria (L.) Druce) in the Management of Dadru w.s.r. to Dermatophytosis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary Outcome -Change in Final Severity Score based on Dermatophytosis Area and Severity Index
研究概览
简要总结
The study entitled Pharmaco-therapeutic Evaluation of Different Parts (Leaf, Stem Bark and Root Bark) of Shami in the Management of Dadru focuses on exploring the therapeutic role of Shami in Dadru. In Ayurveda, Dadru is described as a Kshudra Kushtha, predominantly involving Pitta Kapha dosha with symptoms such as circular patches, itching, redness, and eruptions. Clinically, it corresponds to superficial fungal infections, largely caused by Trichophyton rubrum. Conventional antifungal therapies often face challenges such as recurrence and resistance, highlighting the need for safe, affordable, and effective alternatives. Shami has been traditionally used for skin diseases and possesses antifungal potential, with prior in vitro studies suggesting activity against Trichophyton rubrum and Candida albicans. This research will undertake pharmacognostical, phytochemical, and MIC analyses of Shami’s leaf, root bark, and stem bark, followed by a randomized, single-blind, three arm clinical trial involving 120 patients. Topical creams of 20 percent extracts will be prepared and assessed based on the Dermatophytosis Area and Severity Index, clinical symptom scoring, and Dermatology Life Quality Index. The study aims to compare and establish the relative efficacy of different parts of Shami, thereby contributing evidence-based validation for its role in the management of Dadru.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient with clinical sign and symptoms of Dadru with kandu,raga,pidaka and utsanna mandala.
- •Patients willing to give informed consent and adhere to the study protocol.The patient falls into the mild to moderate category based on body surface area (BSA) involvement, which ranges from 0% to 10%.
排除标准
- •The patients suffering from severe systemic disorders.
- •The pregnant women and lactating mother will be excluded.
- •Known case of skin malignancy.
- •The patient falls into the severe category based on body surface area (BSA) involvement, which is greater than 10%.
结局指标
主要结局
Primary Outcome -Change in Final Severity Score based on Dermatophytosis Area and Severity Index
时间窗: Primary Endpoint: Improvement in the Final Severity Score based on Dermatophytosis Area and Severity Index from baseline to the fourth weeks of the study.
次要结局
- Secondary Outcome -Change in the score of dermatology life quality index (DLQI).(Secondary Endpoint: Improvement in the Dermatology Life Quality Index (DLQI) from baseline to the fourth weeks of the study.)
研究者
Dr. Vipan kumar saraswat
National Institute of Ayurveda
