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临床试验/CTRI/2019/05/019443
CTRI/2019/05/019443尚未招募2 期

Efficacy of a Unani formulation in Bawaseer-e-ghaira (Internal haemorrhoids of first and second degree)- An observational clinical study.

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1.Rectal examination and Proctoscopy

研究概览

简要总结

Haemorrhoids are one of the most common anorectaldiseases of mankind.The term is derived from two Greek words, haima; bloodand rhoos; flowing. The term pile has been derived from Latin word “Pilaâ€which means “a ballâ€.Accordingto Cerato et al, hemorrhoidal diseases affect 4% of theworld population. But according to Ali et al, 50-85% of peoplearound the world had hemorrhoids. Some researchers suggest thatabout 75% of the people are affected with this disease. It is the common cause of lower G.I. bleed and its frequency in Indiais 30-40%. According to Gami, more thanhalf of men and women aged 50 years and above will develop hemorrhoid symptomsduring their lifetime. Hospital based proctoscopy examinations show prevalencerates of hemorrhoids in 86% of patients. The available treatments of disease are symptomatic i.e.avoidanceof excessive straining, better dietary habits supplemented by medication andtopical ointments to keep stools soft and regular. Active treatment includes sclerotherapy,barron’s band ligation, cryotherapy, infrared photo-coagulation and surgicaltreatment.

In the view of high prevalence and nonavailability of affordable treatment without side effect, the present study isaimed to manage the disease with Unani formulation “*Halela,*kabuli, Kahruba shamai, Muqil,Aab-e-gandana, and Roghan-e-gaoâ€9 with main objective to provide cost effective and easily availabletreatment without adverse effect.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

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

入选标准

  • 1.Diagnosed case of internal haemorrhoids of 1st and 2nd degree 2.Age group 18-60 years 3.Both genders; male and female 4.Patients who have agreed to sign the informed consent form and follow up the protocol.

排除标准

  • 1.3rd& 4th degree of haemorrhoids 2.Severe systemic illness 3.Pregnant and lactating women 4.Haemorrhoids associated with other Anorectal diseases like Rectal polyp, Fissure in Ano, Fistula in Ano, Carcinoma of Rectum and Anal canal etc.

结局指标

主要结局

1.Rectal examination and Proctoscopy

时间窗: 45 days

(Bleeding points, Number, Positions & Degree of masses)

时间窗: 45 days

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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