跳至主要内容
临床试验/CTRI/2021/04/032926
CTRI/2021/04/032926尚未招募不适用

A Comparative Study of Marham-e-Safedab with Diltiazem Gel 2% in Shiqaqe Maqad (Anal Fissure).

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Complete Healing Of Anal Fissure

研究概览

简要总结

Fissure in Ano isone of the most common & Painful Proctologic disease affecting a Majorityof the population World wide. According toconventional system of medicine various managements are like Inj. Botulinumtoxin, topical application of Calcium channel blocker (Diltiazem Gel 2%), Localvasodilators (topical Nitrates) etc. but these drugs have some drawbacks likelocal irritation, short duration of action and more systemic absorption sideeffects etc. When conservative treatment fails for more than 6 week thensurgical treatment is required like Lord,sDilation, Fissurectomy or Internal sphincterotomy but these are alsohaving different complications like hemorrhage, Hematoma ,Perianal abscess andincontinence of stools. In view of common prevalence, drawbacks and non-availability of affordable and safe treatment of anal fissures, the presentcomparative study is being designed to manage the anal fissures andEvaluate a Unani formulation viz Marham -e-Safedab as Topical OintmentApplicator with main objective to find out a convenient, non- operative, painless,safe, affordable, efficient remedy with comparison to the Calcium channelblocker (Diltiazem Gel 2%).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

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

入选标准

  • Anterior and /or Posterior Anal Fissure Acute and/or chronic Anal Fissure.

排除标准

  • Patient with 3rd/4th Degree Haemorrhoids or thrombosed pile mass Pregnant women In case of any Malignancy When associated with severe systemic diseases Complicated multiple Fissures.

结局指标

主要结局

Complete Healing Of Anal Fissure

时间窗: 42 Days

次要结局

  • Subjective Parameter -Evaluation Of Pain through Visual Analogue(Scale(VAS))

研究者

申办方类型
Research institution and hospital

研究点 (1)

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