Efficacy of Uá¹taravasá¹i with DhÄnwaná¹aram á¹ailam using Foley’s adapter against using Feeding tube in VÄá¹Äá¹£tÄ«la with special reference to Benign Prostatic Hyperplasia – A Randomised Controlled Non-Inferiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in self-administered IPSS questionnaire score
研究概览
简要总结
The aim of this study is to compare the effectiveness of Uá¹taravasá¹i with DhÄnwaná¹aram á¹ailam administered through Foley’s adapter or feeding tube in treating VÄá¹Äá¹£tÄ«la wsr Benign Prostatic Hyperplasia. This is a randomized controlled open label non-inferiority trial. 24 patients will be recruited from the OPD of VPSV Ayurveda College, Kottakkal using consecutive sampling and assigned to either group by a computer program. The intervention group will receive Uthara vasti with 30ml medicine through Foley’s adapter, while the control group will receive the same through feeding tube. The treatment will be given on alternate days for 14 days. The patients will be followed up for 30 days. Assessment will be done by IPSS score and USG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age between 50 and 70 Prostate volume below 70 cc in USG PSA below 4 ng/ml IPSS between 8 and 19 Post Void Residual Urine Volume greater than or equal to 50.
排除标准
- •Those who are Uá¹taravasá¹i anarha.
- •Diagnosed cases of Malignancy.
- •Sexually Transmitted Diseases (STD).
- •Participants having other Urinary system.
- •pathologies like severe Urinary tract infection, Nephrolithiasis, Urethral stricture, Prostatitis and Congenital deformity of Urogenital system.
- •Uncontrolled Diabetes Mellitus, Hypertension, Hypercholesterolemia.
- •Participants having other systemic pathologies where Uá¹taravasá¹i is difficult to administer.
结局指标
主要结局
Change in self-administered IPSS questionnaire score
时间窗: 15th and 45th day from the starting of procedure
次要结局
- Reduction in Prostate size &(Post void Residual Urine Volume. Samyak laká¹£ana of Uá¹taravasá¹i also be noted)
研究者
Dr Sanal Kumar M P
VPSV Ayurveda College, kottakkal