A Clinical study to evaluate the Efficacy of a Unani Formulation in the management of uncomplicated Urinary Tract infection (Waram-E-Aalate Bawl)-Randomized control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To assess the safety and efficacy of the proposed Unani Formulation on scientific parameters.
研究概览
简要总结
This study is a randomised, parallel group,active control clinical trial to evaluate the Efficacy and safety of the unani drug in the dose of two capsule (each capsule containing 500mg) with Sharbat e Sandal in the management of Uncomplicated Urinary tract infection and to compare it’s efficacy with a standard drug.The microbes responsible for UTI are similar across the world in both advanced and developing nations.These bacteria have developed unique methods of survival and resistance to persist in the urinary system.Unfortunately,UPEC continue to show increased resistance to some of the antibiotics as prescribed in Allopathic system of medicine.
In addition, antibiotic use may harm patients suffering from asymptomatic bacteriuria.It was concluded to be beneficial not to treat younger women suffering from asymptomatic bacteriuria with antibiotics due to a possible protective effect of colonizing bacteria.Solely symptomatic treatment of acute uUTI also seems to be an option.
Therefore,in place of antibiotics prescribed in Allopathic system of medicine and it’s arising resistance towards asymptomatic UTIs,The safety and efficacy of suitable herbal drug Kabab chini(Cubeba officinalis) have not been evaluated on scientific parameters.
Hence,there is a need to develop a safe, efficacious and economical drug on modern scientific parameters from the herbal treasury of Unani medicine for the treatment of uUTI.
The purpose of this study is to provide a safe and effective drug for managing uUTI and to compare it’s efficacy with a standard drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient willing to participate in the study and sign the informed consent form.
- •2.Female patients of the reproductive age group between 20-45 years.
- •3.Presenting with acute following symptoms(Burning micturition,dysuria, frequency and urgency) 4.Diagnose cases of urinalysis showing pus cells (7-10 white blood cells per high-powered field).
排除标准
- •1.Below 20 and 45 years 2.Any signs evoking complicated UTI, pyelonephritis (fever more or equal 38 degree Celsius, back pain,chills and shivers.
- •3.Concomitant vulvovaginitis.
- •4.Conditions leading to complicated infections (Renal diseases, urinary tract abnormalities,past urinary surgery, urine catheterization etc) 5.Pregnancy and lactating mother 6.Cardiovascular diseases and any systematic illness.
- •7.H/o Sexually transmitted diseases 8.Immune compromised pateints.
结局指标
主要结局
1.To assess the safety and efficacy of the proposed Unani Formulation on scientific parameters.
时间窗: Improvement in signs and symptoms of uUTI patient at 15 days from base line
2.To compare the results of Unani Formulation with the standard control in the treatment of uUTI in respect of safety and efficacy.
时间窗: Improvement in signs and symptoms of uUTI patient at 15 days from base line
次要结局
- To evaluate the effect of Unani polyherbal formulation on quality of the patient(Change in urinalysis showing pus cells at 15 days from base line)