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临床试验/CTRI/2024/01/061891
CTRI/2024/01/061891
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Evaluating the anti-microbial efficacy and drug kinetics of Titanium Platelet Rch Fibrin (T-PRF) loaded with Amoxicillin+ Clavulanic acid gel, Metronidazole gel and Neem gel: An In-vitro study

Dr Shiva Shankar Gummaluri1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月31日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Dr Shiva Shankar Gummaluri
入组人数
20
试验地点
1
主要终点
drug kinetics and anti-microbial efficacy

概览

简要总结

20 healthy volunteers will be recruited based on proper inclusion and exclusion criteria and 20 ml of blood will be drawn for anticubital vein. Further T-PRF membrane clots will be prepared by Tunali M et al 2013 protocol and to it Amoxicillin+clavulanate gel, metronidazole gel, neem gel will be incorporated individually and subjected to Drug kinetics analysis and antimicrobial efficacy. Drug kinetics will be checked through spectrophotometric analysis at 0, 2, 24, 48 and 72 hours. Antimicrobial efficacy checked as zone of inhibition diameters at 48 hours.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • subjects who were systemically healthy, willing to participate in study, having greater than 2 lakhs platelets, who do not have any systemic disease.

排除标准

  • subjects under any sought of medications, subjects not willing to take part, smoking, lactating and pregnant females, subjects having any systemic illness were eliminated.

结局指标

主要结局

drug kinetics and anti-microbial efficacy

时间窗: drug kinetics at 0,2, 24, 48, 72 hours and anti-microbial efficacy at 48 hours

次要结局

  • scanning electron microscopy & FT-IR(24 hours)

研究者

发起方
Dr Shiva Shankar Gummaluri
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

Shiva Shankar Gummaluri

GITAM Dental College and Hospital

研究点 (1)

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