An Open Label Randomized Standard Controlled Clinical Study to Assess the Synergistic Efficacy of Two Unani Formulations in the Management of Uncomplicated Urinary Tract Infection (Tadiya-e-Aalat-e-Baul)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total signs and symptoms score mentioned in synopsis
研究概览
简要总结
Sixty patients diagnosed with uncomplicated UTI will be randomly allocated into two groups of 30 using block randomization. The test group will receive Banadiq al Buzoor tablets and Sharbat Aalu Balu twice daily for 21 days, while the control group will receive Nitrofurantoin capsules twice daily for 14 days. Patients will be monitored every 7 days, with safety and efficacy assessed through hemogram, E.S.R., and biochemical indicators for kidney and liver function. Voluntary informed consent will be obtained from all participants. Statistical analysis will be conducted to evaluate the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patient of Uncomplicated UTIs by urine culture and sensitivity .
- •Patients of either gender between the age group of 18 to 65 years.
- •Patient willing to sign the written informed consent to participate in trial.
- •Patient presenting with typical symptoms of UTIs like painful burning sensations Increased frequency of urination Urogenital urgency.
- •Patient presenting with complaint of pain in lower back or pelvic area blood in urine cloudy and bad oduor urine
- •Patients not taking any other drugs for Uncomplicated UTIs.
- •Patients who are willing and able to understand and follow the protocol for the duration of the study.
排除标准
- •Pregnant and lactating women.
- •Patients with urinary tract stricture or any anatomical abnormality.
- •Patient with Diabetes Mellitus.
- •Patient with Hepatic & Renal insufficiency and malignancy.
- •Patient on Immunosuppressants.
- •Patient with STDs or HIV 1 and 2
- •Patient resistant to the standard control drug.
- •nitrofurantoin
- •Patient who fails to give consent.
- •Mentally retarded person.
- •Non ambulatory and Bed ridden patients.
- •Patient willing to discontinue the drugs taking for the treatment of uncomplicated UTIs.
- •Patients with uncontrolled hypertension.
- •Patients with cardiovascular complications.
- •Patients not willing to report for follow up.
结局指标
主要结局
Total signs and symptoms score mentioned in synopsis
时间窗: At baseline,2nd and 3rd week
And improvement in presenting complaints
时间窗: At baseline,2nd and 3rd week
次要结局
- ivestigations Globl score(at the end of 3rd week)
研究者
Dr Mohd Irshad Ahmad
Govt. Tibbi College and Hospital Patna