Evaluation of efficacy and safety of Majoon e Ushba orally and Zimad (a herbomineral unani formulation) topically in the management of Quba (Tinea corporis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1. DSS (Dermatophytosis severity score)
研究概览
简要总结
Quba, also known as Dermatophytosis, is a common fungal infection that affects the keratinized tissues of the body such as skin, hair, and nails. It is caused by a group of fungi known as dermatophytes, which belong to three main general Trichophyton, Microsporum, and Epidermophyton. Globally, around 20 to 25 percent of the population is affected by this condition. In India, the prevalence is particularly high, ranging from 36.6 to 78.4 percent. The infection is classified based on the site affected, such as Tinea capitis for the scalp, Tinea corporis for the body, and others. Tinea corporis is reported to be the most common type in India. It presents as circular lesions on the trunk with red raised borders and a clear center, often accompanied by itching, scaling, and discomfort. In Unani medicine, Quba is described as a type of rough, hyperpigmented patch that is itchy but painless. It is generally circular and caused by factors such as excess heat in the blood, phlegmatic imbalance, and other humoral disturbances. Despite the availability of modern antifungal medicines, the prognosis of dermatophytosis remains poor and the misuse of corticosteroids often worsens the condition. These treatments also carry potential side effects. This study was undertaken to evaluate the safety and effectiveness of Unani formulations, specifically oral Majoon e Ushba and topical Zimad, in managing Quba. These formulations have been traditionally used and are considered safe. The aim is to offer a reliable, safe, and effective alternative treatment for this common condition.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Clinically diagnosed and potassium hydroxide test (KOH) 2.Confirmed cases of dermatophytosis 3.Subjects who have agreed to sign the informed consent form.
排除标准
- •1.Patients suffering from concomitant diseases like psoriasis and eczema.
- •2.Patients suffering from severe systemic and metabolic diseases like diabetes mellitus, hepato renal dysfunctions etc.
- •3.Pregnant and lactating women.
- •4.Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks.
结局指标
主要结局
1. DSS (Dermatophytosis severity score)
时间窗: On Days 1, 14 and 35
2. Mycological cure (KOH test)
时间窗: On Days 1, 14 and 35
次要结局
- DLQI score (Dermatologically life quality index)(1st day and 35 day)
研究者
Abdul Rehman Ali
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal
