A Comparative Random Clinical Trial to compare efficacy of Kanchnaar Guggulu and Kanchnaar Guggulu with Prostate Massage Therapy in management of Vatashtheela w.s.r Benign Prostatic Hyperplasia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (IPSS) under 7
研究概览
简要总结
Vatashtheela is a disease of *mutravaha strotas(*urinary system), One among 12 types of *mutragata(*obstructive uropathy) disorder elaborated by Acharya Sushruta closely resembles to Benign Prostatic Hyperplasia(BPH) of modern science in its signs and symptoms.
The Vatashtheela mutragata reflects the symptoms of urine retention, incomplete voiding, dribbling, hesitancy, dysuria, straining during urination etc. These are the features of lower urinary tract symptoms can be correlated with Benign Prostatic Hyperplasia in modern science.
There have been many studies previously done in Ayurveda on Vatashtheela having special reference to BPH that are known to reduce the symptoms of the disease and improve the overall quality of life. But some patients do not respond the conservative treatment and surgery. That is why we planned this study for management of Vatashtheelaw.s.r BPH.
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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Patients with age above 40 years 2.Patients with International Prostate Symptoms Score(IPSS) under 7 3.Prostate Specific Antigen(PSA) under 6.5ng/ml 4.Post Void Residual Volume under 80ml 5.Urine Flow rate of under 15ml per sec for 2 voids 6.Chronic urinary retention 7.Willing and able to participate in the study for 66 days.
排除标准
- •1.Patient age below 40 and above 70 2.Patients having other urinary system pathology like severe UTI and calculai and urethral stricture 3.Patients suffering from malignanacy of urogenital system like CA of prostate 4.Patients having congenital deformity of urogenital tract 5.BPH with other obstructive uropathy 6.Serum Prostate Specific Antigen(PSA) high level 7.Acute retention of urine 8.Post Void Residual Volume greater than 80ml.
结局指标
主要结局
International Prostate Symptom Score (IPSS) under 7
时间窗: This score can be assessed at every sitting of procedure. In case of oral medicine this can be assessed on 22th day.
次要结局
- Subjective criteria:(International prostate symptom score (IPSS))
研究者
Vishal Saini
Institute For Ayurved Studies And Research