A clinical study to assess the efficacy of a treatment module including Shodhana followed by Shamana in the management of Benign Prostatic Hyperplasia (Mutraghata)
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Patient is able to maintain normal urine flow
研究概览
简要总结
Background: BPH is a common condition that affects most of the adults as they grow older, and it greatly affects the quality of life. Modern treatment methods include oral treatments such as 5α-reductase inhibitors, α1 Adrenergic Antagonists (α1-Blockers), Muscarinic Receptor Antagonists (MRAs) which are known to have potential side effects. Surgical treatment methods such as Trans-Urethral Resection of Prostate (TURP) is also known to have common side effects such as TUR Syndrome etc. There are many studies and treatment methods described in Ayurvedic texts that are known to improve the condition with little or no side-effects. This study aims to define an effective treatment module for BPH management which will be used as a standard.
OBJECTIVES:
Primary:
To assess the efficacy of a Treatment Module including Shodhana followed by Shamana in maintaining the normal urine flow in patients of Benign Prostatic Hyperplasia.
Secondary:
To reduce Prostate Size
To reduce Prostate weight
To improve IPSS in patients of BPH
To validate a Module designed for management of BPH
INVESTIGATIONS
Prostate Specific Antigen (PSA) level before and after treatment
Routine & Microscopic test of Urine
Ultrasonography of Prostate Gland – before and after treatment
Post Voidal Residual Volume – before and after treatment
Other investigations such as Renal Function Test, FBS, PPBS
CRITERIA FOR ASSESSMENT
International Prostate Symptom Score (IPSS)
Uroflowmetry – before and after treatment to assess the peak flow rate
Post Voidal Residual Urine Volume
Gradation of Prostate Size
Gradation of Prostate Weight
Prostate Specific Antigen (PSA) Levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients diagnosed with BPH Grade I, II or III.
- •Patients having classical signs and symptoms of Mutraghata.
- •Patients fit for Anulomana and Uttara Basti.
排除标准
- •Age below 40 years or above 80 years
- •Patients with malignancy, congenital deformities of urogenital tract or any pathology other than BPH
- •Patients with Diabetes Mellitus, Hypertension, Renal disorders or any other systemic disease
- •Patients unfit for Anulomana and Uttara Basti.
结局指标
主要结局
Patient is able to maintain normal urine flow
时间窗: 0th Day, 21st Day, 41st Day, 60th Day
次要结局
- Reduction in Prostate Weight(0th Day, 60th Day)
- Reduction in Prostate size(0th Day, 60th Day)
- Improvement in International Prostate Symptom Score (IPSS)(0th Day, 21st Day, 41st Day, 60th Day)