A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to compare the Efficacy and Safety of Marham-e-DÄd with Terbinafine in the Management of QÅ«bÄ (Ringworm)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Signs and Symptoms Score(TSSS)
研究概览
简要总结
-The prevalence rate of QÅ«bÄ(Ringworm) has been found to be 20-25% worldwide.
-It is more prevalent in tropical and subtropical countries like India where the heat and humidity is high throughout the year. –
-QÅ«bÄ (Ringworm) also has many ill impact on the patient’s quality of life.
-In conventional medicine, some antifungal drugs are used in the treatment of Ringworm, which are becoming resistant to the organism and also have certain adverse effects with antifungal drugs are erythema, itching, dryness, irritation nausea, hepatotoxity, abdominal pain, headache, rashes, hypokalemia and oligozoospermia etc.
-Hence, there is need to search more effective and safe drugs in management of QÅ«bÄ (Ringworm).keeping this in view, a unani formulation Marham-e- DÄd has been selected to evaluate its efficacy and safety in the management of QÅ«bÄ (ringworm)
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Circumscribed lesions having any of the following signs and symptoms on body: .Presence of pruritus and burning .Presence of scales_ .Presence of central clearing .Erythematous papules b) Participants with positive mycology (KOH positive).
- •c)| Participants of either sex in age group of 19-60 years.
排除标准
- •a) Co-morbid conditions of the participants b) Pregnant or Lactating Women c) Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction d) Known cases of Immuno-compromised states (HIV/ AIDS, etc.)/Malignancies Participants not willing to attend treatment schedule regularly e) History of hypersensitivity to Itraconazole and Terbinafine.
- •F) Patient having diabetic.
- •g) Participants using the following medications: .
- •Systemic antifungal within 15 days of baseline visit.
- •Systemic corticosteroids within 15 days of baseline visit.
结局指标
主要结局
Total Signs and Symptoms Score(TSSS)
时间窗: 42 days
次要结局
- 1.Conversion to Negative Mycology(2.Systemic Safety Assesssment)