A prospective open labelled, single arm, non- randomized, single centric, phase II clinical trial to determine the effectiveness of Aali Vidhai Manapagu in the management of Azhal Neer Churukku (Urinary Tract Infection)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF AALI VIDHAI MANAPAGU THE MANAGEMENT OF AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION) . The trial drug AALI VIDHAI MANAPAGU is freshly prepared and will be administrated at a dosage of 20 ml (twice a day orally ) with lukewarm water as adjuvant for 10 days for 40 known AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION) patients (20 OP and 20 IP ) . The primary outcome will be determine the clinical effectiveness of AALI VIDHAI MANAPAGU (INTERNAL) in the management of AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION ). The secondary outcome will be To collect various Siddha literatures and modern journals for literature review on AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION ) ,To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, To perform physicochemical, phytochemical, bio chemical analysis of AALI VIDHAI MANAPAGU To evaluate pharmacological activities of AALI VIDHAI MANAPAGU, To study about the prevalence of AZHAL NEER CHURUKU in relation with diet and lifestyle ,To evaluate Siddha parameters (including Envagai thervu) in AZHAL NEER CHURUKKU during trial period, To evaluate modern parametric changes in AZHAL NEER CHURUKKU.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having symptoms with burning micturition/ dysuria 2.Fever with chills (less than 104 degree F), 3.Frequency of micturition, hematuria, pain over the suprapubic region, and low back pain (Assessed by UTISA questionnaire) 4.Renal calculus( less then 10 mm ) 5.Patients who are willing to go for urine culture & undergo routine blood investigation 6.Patient willing to sign the informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate in the study.
排除标准
- •1.Pregnant 2.Lactating mother 3.Recent malignancy or radiation therapy 4.Patients considered unreliable by the investigator (e.g., drug addiction, alcohol abuse) 5.H/O Sexually transmitted disease 6.Hydronephrosis 7.Medical renal disease 8.Hyper pyrexia.
研究者
Dr T Sathishkumar
Government Siddha Medical College and Hospital