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临床试验/CTRI/2023/04/052077
CTRI/2023/04/052077尚未招募2 期

A comparative evaluation of Marham-e-Basaliqoon versus lateral internal sphincterotomy in treatment of Shiqaq-ul-Maqad(anal fissure). A randomized comparative standard control study

NATIONAL INSTITUTE OF UNANI MEDICINE1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
42
试验地点
1
主要终点
1. Healing of fissure (Yes/No).

研究概览

简要总结

Shuqāq-ul-maq‘ad (fissure in ano), according to the Unani system of medicine, is caused by Hararat-wa-Yabusat (hot & dry temperament) Khushk-Baraz or Shadeed-Qabz (dry hard stool), Waram-e-har (acute inflammation), Ishal (diarrhoea), Fasid-fuzlaat (Morbid substance), Waram-e-Barid-wa-reehi of anal canal, passage of Tez-Akhlāt and zarba-wa-sakta (trauma).

In Classical text books it has been mentioned by almost all Unani physicians that Anal fissure is shigaff(tear) in anal canal caused by various reasons among which most common cause is SÅ«-e-MizÄj-HÄrr-YÄbis of Maqád and passage of dry hard stool. Other causes include passage of AkkÄl khilt (corrosive humours), dietary habits of eating too much Khushk(dry), Tursh(sour), AkkÄlkhilt (corrosive humours), Qabiz(astringent) items, trauma, external BurÅ«dat and as a complication of BawÄsÄ«r & NÄsÅ«r . In Unani system of medicine the Usool-e-Ilaj (principle of treatment) of fissure in ano is almost same as in allopathic system of medicine, such as use of high fibrous diet and laxatives. Avoidance of Tursh (sour), Qabiz(Constipative) and Khushk (dry) items . In addition several single and compound Unani drugs are indicated for anal fissures treatment having property of Mundammil(Healing), Muhallil-e-Awraam(Anti- inflammatory), Muzliq(Lubricant), Murattib(Humectant), Mulayyin (Laxative) & Mujaffif (Desiccants).

Number of formulations are mentioned in classical literature of Unani system of  medicine for treatment of anal fissures. So, using these formulations for treatment will provide an inexpensive, effective and alternative way for the management of anal fissure. So, in view of common prevalence and drawbacks like non-availability of affordable and safe treatment of anal fissure in conventional system of medicine the present study is being designed to manage the anal fissure by application of a Unani formulation Marham-e-Basaliqoon  with main objective to find out a convenient non operative, painless, safe, affordable and efficient remedy and this classical medicine will be compared with Lateral internal sphincterotomy.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Anal Fissure.

排除标准

  • Fissure associated with third and fourth degree or thrombosed piles.
  • Malignancy.
  • Severe systemic diseases.
  • Multiple fissures.
  • Pregnant women.

结局指标

主要结局

1. Healing of fissure (Yes/No).

时间窗: 21 days

3. Per rectal bleeding

时间窗: 21 days

2. Pain during and after defecation (VAS) 0-10 grade.

时间窗: 21 days

次要结局

  • 1. Tenderness on Digital examination (Yes/No).(2. Anal sphincter Spasm (Yes/No).)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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Unani treatment for fissure in ano | 临床试验