Comparative evalutaion of Efficacy of Sahacharadi Tail Uttarbasti with Bala Tail Matarbasti in the Management of Vatashthila (Benign Prostatic Hyperplasia)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- A decrease in International Prostate System (I-PSS) Score
研究概览
简要总结
The study aims to compare the efficacy of Sahacharadi Tail Uttarbasti and Bala Tail Matrabasti in managing Vatashthila (Benign Prostatic Hyperplasia, BPH). Primary objectives include evaluating the efficacy of both treatments individually and comparing their effectiveness. Secondary objectives involve the pharmaceutical preparation and analysis of the medicated oils. Data will be sourced from classical texts and patients selected from the Shalyatantra OPD & IPD at Mahatma Gandhi Ayurved College, Wardha. The study design is a randomized clinical trial involving 40 patients divided into two groups: Group A receiving Sahacharadi Tail Uttarvasti and Group B receiving Bala Tail Matrabasti, both supplemented with Cap Kushmandadi Yoga. Patients will be assessed on days 0, 7, 14, and 21, with follow-ups on days 21, 28, and 35. Inclusion criteria include patients aged 35-85 with mild to moderate BPH, while exclusion criteria cover patients with severe BPH, systemic disorders, and other specific conditions. The assessment will utilize both subjective (AUA-SI or I-PSS) and objective (USG) criteria. Data analysis will involve the Wilcoxon Rank Sum Test, and the study’s results, discussion, and conclusions will be drawn post-analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- Male
入选标准
- •Patients willing with Written informed Consent for will be taken.
- •Patient in the age group between 35-85years.
- •Patients with having mild to moderate BPH having Prostate size up to 50gm (Grade 3) will be included after screening.
- •Patients who are indicated for Matrabasti.
排除标准
- •1.Patients of Grade 4 BPH i.e. above (50gm).
- •2.Patient suffering from Systemic disorders like uncontrolled Diabetes mellitus, Tuberculosis, Hypertension.
- •3.Urethral Stricture 4.Functional BOO (Bladder Outflow Obstruction) due to neurological conditions like CVA, Tabes Dorsalis, Parkinsonism, Disseminated Sclerosis, Loss of Neuro vesicle co-ordination, Syringomyelia, Alzheimers disease.
- •5.Carcinoma of Prostate 6.Diverticulum of the bladder 7.Trigone Hyperplasia 8.Disability due to old age and serious systemic illness 9.Acute and chronic Retention of urine.
结局指标
主要结局
A decrease in International Prostate System (I-PSS) Score
时间窗: 1st follow up day 21 | 2nd follow up day 28 | 3rd follow up day 35
次要结局
- an increase in quality of lie due to urinary symptoms(1st follow up day 21)
研究者
Dr Sheetal Asutkar
Mahatma Gandhi Ayurveda College Hospital and Research Centre
