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临床试验/CTRI/2024/01/061906
CTRI/2024/01/061906尚未招募4 期

Comparative study on efficacy of oral ultramicrosized Griseofulvin and Itraconazole on dermatophytic infection of skin

Eras Lucknow Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年1月30日最近更新:

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

发起方
Eras Lucknow Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Amarjeet

ERA lucknow medical college

研究点 (1)

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