Preclinical and Clinical studies to evaluate the safety and efficacy of Unani Topical Formulation for Dermatophytosis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
研究概览
简要总结
Study will be conducted on 30 patients of either sex supported by inclusion, exclusion criteria with informed consent.
Prior to the conduction of the study, safety evaluation of the formulation was evaluated. The following parameters also being noted:
1- Primary Irritation study: 24-, 48-hour 72 or 96-hour single-application patch tests to evaluate the primary irritation (acute skin irritation) potential of test drug, if any.
2-Cumulative Patch Irritation study: It is conducted to evaluate the test drug to assess if a chemical ingredient present in the test drug have the potential to cause contact irritation or contact allergy in the skin. 14-day or 21-day patch test is used to investigate the potential irritation from chronic exposure.
3-Forearm Controlled application test (FCAT): Helps to quickly evaluate the relative skin benefits of various skin formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •fungal hyphae in a 10% potassium hydroxide (KOH) Patients aged 14year old to 65 years old.
排除标准
- •Immunocompromised Pregnant ladies Lactating women Patients with secondarily infected or eczematized lesions Medical comorbidities Uncontrolled Diabetes.
结局指标
主要结局
To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
时间窗: To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
次要结局
- Correlate the efficacy with the MIC.(20/04/25)
研究者
PROF ZAMIR AHMAD
AJMAL KHAN TIBBIYA COLLEGE