Role of Individualised Homoeopathic Medicine Using Fifty Millesimal Potency In The Treatment of Benign Prostatic Hyperplasia: An Open Label Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- AMERICAN UROLOGICAL ASSOCIATION Symptom Score (AUASS)
研究概览
简要总结
A. Study will be conducted in OPD of National Institute of Homoeopathy for a duration of 12 months, wherein, each patient will be followed up for 6 months. B. Inclusion and exclusion criteria will be followed. C. After obtaining written consent, preliminary screening will be done and the eligible patients will be recruited in the study. D. A detailed and thorough case taking of each patient will be done. E. AUASS, USG for prostate size and residual urine volume will be assessed at baseline. F. Clinical examinations and relevant investigation will be done as per the need of each case. G. Final selection of single individualised medicine shall be based on case taking in adherence with the standard homoeopathic guidelines, symptom similarity, analysis and evaluation of the symptom totality and after conclusion with Materia Medica. H. Indicated medicines will be dispensed to the patients from the pharmacy of NIH in fifty millesimal potency. I. Each enrolled case will be followed up monthly, USG-Pelvis will be done at the baseline and at 6th month to assess/compare the size of the prostate gland and RUV. The assessment of the outcome of the treatment will be done using AUASS gradation at baseline, third month and at 6th month.
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
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •A) Patients of age group of 40-80 years B) Patients presenting symptoms of Benign prostatic hyperplasia with or without evidence of bladder outflow obstruction with AUASS more than 7 C) Patient suffering from cases of Benign Prostatic Hyperplasia diagnosed radiologically (USG Pelvis) and Ultrasonographic examination of prostate weight more than 20 g or 20 cc and RUV of more than 30ml D) Male patients of all religions and of different socioeconomic status E) Patients with known but controlled systemic diseases F) Patients who are willing to give consent to participate in the study G) Patient who can read and/or understand Hindi or Bengali or English.
排除标准
- •A) Patients with Serum Prostate specific antigen (PSA) more than 4 nmol per mL to rule out suspected prostatic malignancy B) Cases suffering from uncontrolled systemic illness or life-threatening conditions C) Patient suffering from complete retention of urine for more than 24hrs D) Patient having any psychiatric illness.
结局指标
主要结局
AMERICAN UROLOGICAL ASSOCIATION Symptom Score (AUASS)
时间窗: Baseline, 3rd month and 6th month
次要结局
- USG for prostate size and residual urine volume(Baseline and 6th month)
研究者
Jyotidarshanee
National Institute of Homoeopathy