跳至主要内容
临床试验/CTRI/2025/07/090686
CTRI/2025/07/090686尚未招募不适用

Evaluation of YKL-40 and LL-37 levels in saliva of children with Down syndrome: A cross sectional study.

Dr Prapti Subhash Gayakwad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
8 weeks

研究概览

简要总结

This study is a cross sectional study, double blinded, single center trial comparing the levels of YKL-40 and LL-37 levels in the saliva of children with Down syndrome and healthy children in 8 to 15 years old children that will be conducted in India. This study will be carried over the period of six months, and the saliva sample collection will be done in Coachmans position. The samples will be stored in -80 degrees after centrifugation. After collection of all the samples they will be sent for ELISA running and the data will be subjected to the statistical analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
8.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Children with Down Syndrome in the age group of 8 to 15years.
  • Cooperative children based on Frankel behaviour rating scale 3 and 4.

排除标准

  • Children on long term medication
  • Down syndromic children who were extremely uncooperative
  • Children if they had taken antibiotics or anti inflammatory drugs
  • Children with severs intellectual disability and or cardiac condition present along with Down Syndrome.

结局指标

主要结局

8 weeks

时间窗: base line

次要结局

  • Inflammatory biomarker levels will be higher in Down syndrome patients.(One year)

研究者

发起方
Dr Prapti Subhash Gayakwad
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Prapti Subhash Gayakwad

The Oxford Dental College Bangalore

研究点 (1)

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