Evaluation of the efficacy of topical satt-i-barg-e- panwad with vinegar in the treatment of tinea cruris (Quba)-a single blind randomized standard controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Change in Investigator’s global assessment(IGA)
研究概览
简要总结
Dermatophytosis is a roughness of the surface of the skin, which is associated with itching, scaling, and dryness. Sometime fish like scales may also shed off. It may be black or red in colour. Usually the periphery is red and occasionally there may be oozing of yellowish fluid. All these condition develop according to pathogenic dermatophytes. There are three different types of fungi which causes tinea cruris namely Microsporum, Trichophyton, and Epidermophyton. Dermatophytosis refer to superficial fungal infection of keratinized tissues caused by keratinophilic dermatophytes. Tinea varies with the site of infections as tinea corporis (at trunk region), tinea cruris(at groin region),tinea capitis(at head),tinea faciei(face),tinea pedis(feet),tinea manuum(hand), tinea unguium(nails).
According to world health organization (WHO), the prevalence rate of superficial mycotic infection worldwide has been found to be 20-25%. Its prevalence varies indifferent countries. Tinea corporis (78.1%) was the commonest clinical presentation, followed by tinea cruris (10.1%), tinea manuum (2.5%), tinea faciei (1.8%), and tinea pedis (0.7%). It is more prevalent in tropical and subtropical countries like india where the heat and humidity is high for most part of the year. The dealcoholized leaves extract has shown the significant antifungal activity to inhibit the growth of candida albicans, aspergillus niger,saccharomyces cerevisiae and trichophyton mentagrophytes.
Antifungal drugs exhibit marked adverse effects like hepatotoxicity, nephrotoxicity, and myelotoxicity. Resistance may be developed across most pathogens and causes drug target overexpression, efflux pump activation, and amino acid substitution. The experimental antifungal drugs in clinical trials are also reviewed. Whereas some intrinsic resistance has been found naturally, e.g., fluconazole-resistant. the acquired resistance has been a consequence of long-term therapies, widespread prophylaxis, or use of antifungals in agriculture, especially in the case of triazoles. Environmental exposure of fumigatus to triazole fungicides may explain their resistance in azole-naïve patients. Additionally, secondary resistance may occur after vertical and horizontal transmission in both animals and humans. Hence it is the need of the day to provide a safe and effective medicine, this was the main motivating factor behind the selection of this study, i.e., to evaluate safety and efficacy of Sat-e-barg-e-panwad as topical application in patients of quba
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 diagnosed with tinea cruris (skin of the genitals, inner thighs and buttocks) clinically as well as by KOH mount test without nail and scalp involvement.
- •Patient not taking any other drugs for tinea cruris.
- •Patient who are willing and able to provide informed consent.
- •Patient who are willing and able to understand and follow the protocol for the duration of the study.
排除标准
- •Presence of complications such as secondary bacterial infection of the lesions.
- •Patients of tinea at other parts of body except tinea cruris.
- •Patients already on topical and/or systemic antifungal treatment (1 week of topical therapy and/or 4 weeks of systemic antifungal therapy before baseline visit)
- •patients with uncontrolled diabetes.
- •Immunosuppressant patients like AIDS/HIV infection.
- •pregnant and lactating women.
- •Noncompliance with the trial protocol.
结局指标
主要结局
1. Change in Investigator’s global assessment(IGA)
时间窗: at the baseline and at 6 week
2. Mycological cure: Clinically suspected cases of tinea cruris will be confirmed by skin scraping and KOH preparation, by visualizing presence or absence of long, narrow, septate and branching hyphae under microscope at baseline and at the conclusion of trial.
时间窗: at the baseline and at 6 week
次要结局
- 1. Change in TCS (Total clinical score.(2. Changes in Dermatology Life Quality Index.)
研究者
Shiba Fathima
luqman unani medical college bijapur
