CTRI/2023/01/048858尚未招募4 期
Clinical and Dermoscopic evaluation to study the effectiveness of Metformin vs Pioglitazone in Acanthosis Nigricans - A Randomised Control Trial.
KLE Academy of Higher Education and Research - KLE University Grant1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年1月15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
- 64
- 试验地点
- 1
- 主要终点
- Difference in the reduction of neck lesions of Acanthosis Nigricans calculated using Burkes Grading
研究概览
简要总结
This study is a randomized open label trial comparing the clinical and dermoscopic effectiveness of Metformin 500mg BD with Pioglitazone 7.5 mg BD in Acanthosis Nigricans patients in a tertiary care hospital in Karnataka. The primary outcomes being clinical effectiveness calculated by Burkes Grading and secondary outcome by Dermocopic evaluation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Adult patients (≥18 years) with acanthosis nigricans attending the outpatient department of dermatology in KLE Prabhakar Kore Hospital •Patients from whom written informed consent is obtained.
排除标准
- •â€¢Patients already taking any oral hypoglycemic drug.
- •â€¢Patient diagnosed as Type 1 Diabetes Mellitus •Patient diagnosed as Drug induced AN •Patients diagnosed as AN due to known malignancy •Pregnant and lactating mothers •Known allergic reaction to either Metformin or Pioglitazone •Contraindicated for taking metformin or Pioglitazone.
结局指标
主要结局
Difference in the reduction of neck lesions of Acanthosis Nigricans calculated using Burkes Grading
时间窗: At the end of 12 weeks
次要结局
- Dermoscopic evaluation of reduction of severity of neck lesions in Acanthosis Nigricans(At the end of 12 weeks)
研究者
研究点 (1)
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