Comparative study on efficacy of oral ultramicrosized Griseofulvin and Itraconazole on dermatophytic infection of skin
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To observe the efficacy of oral Itraconazole and Ultramicrosized Griseofulvin in dermatophytic infection.
研究概览
简要总结
A total of 240 patients presenting to the Department of Dermatology, Eras Lucknow Medical College and Hospital, Lucknow of clinical diagnosis of Tinea Corporis and Tinea Cruris confirmed by potassium hydroxide (KOH) test will be approached for participation in the study. Patients meeting the inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History, complete clinical & micobiological examination with photographic documentation will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups – A and B each containing 120 individuals. In group A – Patients will be given oral Itraconazole 100mg twice daily for 8 weeks. In group B – Patients will be given oral ultramicrosized Griseofulvin 500 mg for 8 weeks. Patients will be followed up at 2, 4, and 8 weeks and at each follow-up visit assessment of clinical response to treatment and photograph will be taken and therapeutic efficacy will be graded.
If at any point, any patient withdraws the consent or does not come for 2 consecutive follow-ups despite telephonic reminders. He/She shall be considered dropped out of the study. If and when required CBC, LFT and KFT will be done if abnormality detected, then patient will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Freshly diagnosed patients of age 18 years and above with clinical diagnosis of tinea corporis and tinea cruris confirmed by potassium hydroxide (KOH) test attending the dermatology OPD at ELMC&H.
排除标准
- •Previously treated patient within 3 months.Patients with pre-existing renal disease, hepatic disease and cardiac disease.Pregnant & lactating women.
结局指标
主要结局
To observe the efficacy of oral Itraconazole and Ultramicrosized Griseofulvin in dermatophytic infection.
时间窗: 0,2,4 and 8 weeks
次要结局
- To study the clinical response of dermatophytic infection to oral Itraconazole.(To study the clinical response of dermatophytic infection to oral Ultramicrosized Griseofulvin)
研究者
Amarjeet
ERA lucknow medical college
