Comparative clinical effect of Balataila as Uttara Basti and Matra Basti along with Kanchanar Guggulu in management of Mootraghata(Benign prostate hyperplasia) A open label clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of BPH
研究概览
简要总结
The research study entitled “Comparative clinical effect of Balataila as Uttara Basti and Matra Basti along with Kanchanar Guggulu in management of Mootraghata (Benign prostate hyperplasia) A open-label clinical trial -[BPH] †Aim and Objective of this study was to compare the clinical effect of Balataila in the form of Uttara Basti and Matra Basti along with Kanchanar Guggulu orally in the management of Mootraghata(BPH). In this trial total of 100 Patients having signs & symptoms of Mootraghata will be divided into two groups 50 in each group by computer generated Random number table method. In Group A 50 Patients will be treated with Balataila Uttarbasti for the period of 7 days with 7 days interval along with oral medication of Kanchanar Guggulu 2 Tab Thrice a day for 30 days while in Group B 50 Patients will be treated with Balataila Matra Basti daily along with oral medication of Kanchanar Guggulu 2 Tab Thrice a day for 30 days. Follow will for 2 months in both the groups. Before treatment, routine hematological, biochemical, urine examination will be carried out. The assessment will be done after the completion of therapy in parameters including subjective and objective criteria like Urine flow rate (UFR), Post voidal residual urine (PVRU), and Size of prostrate by USG. Effect of therapy will be assessed statically after completion of study in stipulated time
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Grade 1 to Grade 3 BPH 2.Weight of prostate 30 to 85 gm 3.Patients having signs and symptoms of Mootraghata (BPH) 4.Patients with controlled diabetes mellitus 5.Patient with controlled blood pressure.
排除标准
- •1.Age below 40years and above 60 years 2.Grade 4 BPH 3.Weight of prostate more than 85 gm 4.Patients with uncontrolled Diabetes mellitus (FBS more than 140mg/dl PPBS more than 180mg/dl) 5.Patient of Uncontrolled Hypertension ICD-10(BP more than 140/90 mm of Hg) 6.Known case of cardiac diseases.
- •7.Patients of malignancy, congenital deformities of the urogenital tract, or any abdominopelvic pathology other than BPH 8.Tuberculosis Paralysis Parkinsonism etc will be excluded.
结局指标
主要结局
Relief in signs and symptoms of BPH
时间窗: one month
次要结局
- Relief in signs and symptoms of BPH(2 month)