Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Urine Culture Examination
研究概览
简要总结
The main objectives of the study are; to determine the efficacy of test drug Crano-cure for the treatment of urinary tract infection, to compare the effectiveness of Polyherbal formulation Crano-cure vs. Standard allopathic. Antibacterial/ antibiotic (Ciprofloxacin 500 mg) in treatment of UTI, to assess the safety of trial drug.
Research literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity.
详细描述
A urinary tract infection (UTI) is the infection of kidney that affects urinary tract. It affects the urinary bladder (cystitis) and kidney (pyelonephritis). Symptoms of urinary bladder infection are painful urination, frequent micturation, and urinary incontinence. Symptoms of infection in kidney include pyrexia and lumber pain also in addition to symptoms of a lower urinary tract infection and rarely blood in the urine. In older age and in young adults, symptoms may be unclear or non-specific [1].
Urinary tract infections are grouped into two types; complicated and uncomplicated. In uncomplicated cases of urinary tract infections, the function of urinary tract system does not disturb. In complicated UTI, the normal function of UT system disturbs [2].
Uncomplicated UTI is usually caused by E. coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis Enterococcus spp. While complicated UTI is caused by Similar organisms which causes uncomplicated UTI Staphylococcus spp. Enterococcus spp. P. aeruginosa
Current studies on the prevalence of urinary tract infections approximately one third population of the world has been suffering from this disease. This disease causes Pyuria, burning urination, heamaturia, pyrexia, Vaginal itching, Offensive" smell and turbid urine, urinate frequent, urgency to urinate and suprapubic pain or pain in pelvis. It is not life-threatening disease. Different antibacterial/ antibiotics are available such as Co-trimaxazole, amoxicillin, nitrofurantoin, trimethoprim, combination of trimethoprim and sulfamethoxazole and quinolone antibiotics is taken as a choice for the treatment of UTI [3]. The antibacterial agents/ antibiotic available but they are limited in number, have adverse effects, resistance of bacteria to these agents and relapse of the UTI. In order to overcome the problem of less availability of drugs needed to treat urinary tract infection, with traditional medicine derived from medicinal plants. This encouraged the search for new and dynamic antibacterial agents from plant sources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 to 60 years with symptomatic acute urinary tract infection.
- •Willing to participate in the study
- •Non-pregnant adult females.
- •Clinical signs and symptoms of a UTI (e.g., dysuria, frequency, urgency to urinate, Burning sensations during urination, Hematuria, suprapubic pain) with onset of symptoms < 72 hours prior to study entry.
- •One positive pre-treatment clean-catch midstream urine culture within 48 hours of enrollment in the study, defined as > 105 CFU/mL.
- •Patients having all socioeconomic classes including lower, middle and higher.
- •In-vitro susceptibility testing of the uropathogen to test and control drug.
排除标准
- •• Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control. If an antimicrobial agent is to be studied for the treatment of UTI in pregnant women, this proposal should be justified, the risk/benefit expectations explained, and the issue presented to the division.
- •Three or more episodes of acute uncomplicated UTI in the past 12 months.
- •Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder.
- •Patients with onset of symptoms 96 hours or more prior to entry.
- •Patients with a temperature > 1010 F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection.
- •Patients with known or suspected hypersensitivity to the test or control drug.
- •Patients who received treatment with other antimicrobials within 48 hours prior to entry.
- •Patient suffering in chronic illness Diabetes mellitus, chronic liver diseases
研究组 & 干预措施
Test Group
No of enrolled Pts. 102 Drug Cap. Crano-cure 500mg. Quantity 500 mg Bd Usage 1 cap Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks
干预措施: Crano-cure (Dietary Supplement)
control group
No of enrolled Pts. 103 Drug Tab. Ciprofloxacin 500mg Quantity 500mg Bd Usage 1 Tab Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks
干预措施: Ciprofloxacin 500 mg (Drug)
结局指标
主要结局
Urine Culture Examination
时间窗: 15 days
Urine Culture examination for Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis
次要结局
未报告次要终点
研究者
Hafiz Abdul Sattar Hashmi
Principal Investigator
Islamia University of Bahawalpur