A Clinical Study on the Management of Urinary Tract Infection (Tadiya-e-Majra-e-Baul) caused by E. coli with a Unani Polyherbal Formulation, An Open Single Arm Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of the proposed Unani Polyherbal Formulation for the management of Urinary Tract Infection caused by E. coli.
研究概览
简要总结
It is a clinical study on the management of Urinary Tract Infection caused by E. coli with a Unani Polyherbal Formulation containing seven drugs namely, Tribulus terrestris, Phyllanthus niruri, Piper cubeba, Cichorium intybus, Apium Graveolens, Glycyrrhiza glabra and Tinospora cordifolia. It would be an Open Single Arm study. Duration of the study will be 1.5 years and duration of the protocol therapy will be 6 weeks. 40 patients will be included in the study. Patient will be given the test drug, prepared in capsule form of Unani Polyherbal Formulation (extract 500mg) thrice a day orally. The safety and efficacy of the test drug will be ensured by monitoring the hemogram with E.S.R. and serological indicators for kidney and liver functions.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •DIAGNOSED PATIENTS OF E.
- •COLI INDUCED URINARY TRACT INFECTION (BY URINE CULTURE) WILLING TO PARTICIPATE AND SIGN THE INFORMED UNDERSTOOD CONSENT FORM.
排除标准
- •PATIENTS WITH ANY ANATOMICAL ABNORMALITY OF URINARY TRACT, DIABETES MELLITUS, HEPATIC AND RENAL INSUFFICIENCY, PREGNANT AND LACTATING WOMEN, STDs AND HIV.
结局指标
主要结局
To evaluate the safety and efficacy of the proposed Unani Polyherbal Formulation for the management of Urinary Tract Infection caused by E. coli.
时间窗: Clinical examination and subjective evaluation would be done at baseline, 7 day, 15 day, 30 day and 42 day. Safety evaluation will be performed and recorded at baseline, 7 day and 42 day. | CBC, LFT & KFT would be done.
次要结局
- To develop a safe, efficacious and cost-effective drug from a herbal source for the management of Urinary Tract Infection caused by E. coli(For safety evaluation CBC, LFT & KFT would be done.)