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临床试验/CTRI/2024/10/074891
CTRI/2024/10/074891已完成不适用

Role of Oral Lactoferrin in the treatment of Mild to Moderate Ulcerative Colitis - A Pilot Randomized controlled trial

IMS BHU1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
difference in treatment response in 2 groups, which is defined by decrease in complete mayo score by 3 points

研究概览

简要总结

it is a pilot , placebo controlled , double blind , randomized controlled trial to be conducted in the  department of gastroenterology at IMS BHU, Varanasi. The purpose  of the study is to determine the role of oral lactoferrin in the treatment of mild to moderate ulcerative colitis. The study is approved by the institutional ethics committee at IMS BHU.  Patients ,aged 18-60 years ,having mild to moderate ulcerative colitis and presenting to gastroenterology OPD , will be enrolled in the study  after applying inclusion and exclusion criteria and  taking written and informed consent of the patient and will be randomized into 2 groups - oral lactoferrin plus standard medical therapy versus standard medical therapy alone and group A will be given oral  lactoferrin in doses of 1 gm/day along with standard medical therapy while group B will be given placebo along with standard medical therapy . both group patient will be followed up for study duration of 3 months and at the end of 3 months, treatment response will be assessed using complete mayo score .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • all patients in above age group with mild to moderate ulcerative colitis defined by complete mayo score 3-10 and UCEIS score greater than 1 will be included in the study.

排除标准

  • patients requiring hospitalization or colectomy, patients having history of surgery for ulcerative colitis, patients having concomitant GI infections and patients who are not giving consent for the study are to be excluded.

结局指标

主要结局

difference in treatment response in 2 groups, which is defined by decrease in complete mayo score by 3 points

时间窗: At baseline & 3 months

次要结局

  • difference in the mean change in levels of biochemical variables such as hemoglobin , CRP levels & fecal calprotectin levels(At baseline & 3 months time)

研究者

发起方
IMS BHU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dawesh Prakash Yadav

IMS BHU, Varanasi

研究点 (1)

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