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临床试验/CTRI/2020/02/023404
CTRI/2020/02/023404已完成不适用

Efficacy of a Unani pharmacopeial formulation in Waram Majra-i-Bawl in women: A randomized standard controlled study

National Institute of Unani Mediicne1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年2月20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
10
试验地点
1
主要终点
Change in clinical features (urinary frequency, urgency, dysuria or haematuria) assessed by UTISA questionnaire

研究概览

简要总结

In Unani medicine*,Waram Majra-i-Bawl (urinary tract infection)describedas an infection that starts in the urinary system which includes Waramal-Kulya, Waram al-Mathana  and Waramal-Ahlil1which may be considered as similar with clinical findings of urinarytract infection (UTI), described in conventionalmedicine.Antibiotics are themain stay treatment for acute and recurrent UTI.  However, antibiotic resistance is estimated20% for trimethoprim and cephlosporins and 50% for amoxicillin.Further,it is predicted that antibiotic resistance will continue to increase. Sometimesside effects may require treatment to be withdrawn. Once prophylaxis isdiscontinued even after extended periods of therapy 50% to 60% of women becomere infected with in three months.Therefore, the need for alternativetherapies for UTI is evident. For centuries plants have been used throughoutthe world as drugs and remedies for various diseases.Unaniclassical texts and pharmacopeia are enriched with medicines useful in Waram Majra-i-Bawl.* Below mentioned compound formulation of Unani pharmacopeia is usefulin Waram Majra-i-Bawl, contains Tukhme Khayarein,Tukhme Kaddu, Khurfa, Tukhme Khubbazi, and Parsiaavashaan. These plant products possesses Muhallilal-Waram, Musakkin-i-Alam, Mudirr-i-Bawl, and D**afi‘-i-‘Ufunat properties.Pharmacologically they are proven for antimicrobial and anti-inflammatoryproperties.  This is a pilot study on ten patients as advised by the ethical committee.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • Women diagnosed with clinical features such as Pusht me Dard, Usr al-bawl(dysuria), Bawl al-Dam(haematuria), Salsal al-Bawl(urgency), Hurqa al-Bawl(Burning), Taqtir al-Bawl (dribbling).
  • Clinical features of uncomplicated urinary tract infection (uUTI) symptom as per UTI Assessment (UTISA) questionnaire.

排除标准

  • Women aged up to 18 years and over 60 years.
  • Pregnant and lactating women Those with complicated UTI such as associated with pyelonephritis, urolithiasis, diabetes, neurological conditions or urinary tract obstructions.
  • Women who will be catheterised.
  • Hypersensitivity to nitrofurantoin and impaired renal function.

结局指标

主要结局

Change in clinical features (urinary frequency, urgency, dysuria or haematuria) assessed by UTISA questionnaire

时间窗: after trial on 9th or 10th day

次要结局

  • Reduction in Severity (e.g., intensity of pain, urgency, frequency and burning) of uncomplicated UTI.6(2. Improvements in quality of life (as estimated by validated outcomes measures SF-12).)

研究者

发起方
National Institute of Unani Mediicne
申办方类型
Research institution and hospital

研究点 (1)

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