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临床试验/CTRI/2018/01/011101
CTRI/2018/01/011101招募中不适用

Study of the clinical outcomes following outpatient management of early stage Haemorrhoids

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Relief of symptoms of bleeding per rectum,pain/discomfort, post procedure symptoms

研究概览

简要总结

A total of 120 patients of grade 1 and 2 haemorrhoids who are symptomatic will be the part of this trail. It will be a randomized parallel group, multiple arm trial. One group will treated by Rubber band liagation, followed by antibiotic cover, laxatives and standard analgesia( Lignocaine gel 2% and Paracetamol tablet 50 mg/kg/day). Second group will be treated with Injection Sclerotherapy (Polidocanol 1 %), followed by antibiotic cover, laxatives and standard analgesia (Lignocaine gel 2 % and Paracetamol 50 mg/kg/day). Third group will be treated with systemic Flavanoids (Tablet Daflon 500 mg twice a day), sitz bath, laxatives and standard analgesia (Lignocaine gel 2 % and Paracetamol 50 mg/kg/day). Therapy will be assessed in terms of patient comfort, symptom relief, complications if any and complete resolution of the disease. Analysis of the data will be done by an appropriate statistical tests.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All symptomatic patients with grade 1 and 2 haemorrhoids.

排除标准

  • Patients of haemorrhoids grade 1 & 2 with 1.Rectal carcinoma 2.Hepatic cirrhosis / Portal hypertension 3.Recurrent / treated haemorrhoids 4.Associated anal pathology with fissure/ fistula.

结局指标

主要结局

Relief of symptoms of bleeding per rectum,pain/discomfort, post procedure symptoms

时间窗: Post procedure/intervention day 01, 07 and 30

次要结局

  • Residual haemorrhoids(3 months)

研究者

申办方类型
Government medical college

研究点 (1)

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