A Randomized Controlled Clinical Trial To Evaluate The Efficacy of Devdarvyadi Churna In The Management Of Vatashthila w.s.r. To BPH (Benign Prostate Hyperplasia)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the efficacy of Devdarvyadi Churna in the management of Vatashthila w.s.r to BPH
研究概览
简要总结
Title:- A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Devdarvyadi Churna In The Management Of Vatashthila w.s.r. To BPH (Benign Prostate Hyperplasia).
Null Hypothesis:-**Devdarvyadi Churnais not significantly effective in Vatashthila (BPH).
Alternate Hypothesis:- Devdarvyadi Churna is significantly effective in Vatashthila(BPH).
Study design:- Simple Randomized Controlled Clinical Trial.
Inclusive Criteria:-
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Age: Patients age between 45 to 70 years.
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Patients with mild and moderate symptoms as per American Urological Association score (IPSS) given for BPH.
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Patients having samanya lakshana(Symptoms) of Vatashthila(BPH).
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Patients will be included irrespective of their caste, religion, economic status, occupation.
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Patients only those who are ready to give written consent will be selected.
Exclusive Criteria:-
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Age: Patients age less than 45 years and more than 70 years.
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Patients having – Acute urinary retention, Stricture of Urethra, Carcinoma of Prostate, Bladder polyp, Hydronephrosis, Congenital contracture of Bladder neck, Carcinoma of Urinary tract, Neurogenic bladder.
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Patients with severe systemic diseases like- Renal failure, Cardiovascular disorders, uncontrolled diabeties mellitus and hypertension, Tuberculosis, HIV- Immuno compromised patients.
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Patients those who are not ready to give written consent.
Sample size:- Total 60 (30 for each group).
Patients coming in OPD and IPD of Shalyatantra department of our hospital with complaints of Vatashtila(BPH). Simple randomized sampling ( Lottery Method).
Group A:- Devdarvyadi Churna.
Group B:- Tab. Himplasia.
Total duration of drug administration is 90 days. The mode of drug administration will be by oral route.
Followup:- Followup will be done on 15th,30th & 90th day.
Result:- Result will be drawn as per assessment criteria & statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with mild and moderate symptoms as per American Urological Association score (IPSS) given for BPH.
- •Patients having samanya lakshana(Symptoms) of Vatashthila(BPH).
- •Patients will be included irrespective of their caste, religion, economic status, occupation.
- •Patients only those who are ready to give written consent will be selected.
排除标准
- •Patients having – Acute urinary retention, Stricture of Urethra, Carcinoma of Prostate, Bladder polyp, Hydronephrosis, Congenital contracture of Bladder neck, Carcinoma of Urinary tract, Neurogenic bladder.
- •Patients with severe systemic diseases like- Renal failure, Cardiovascular disorders, uncontrolled diabetes mellitus and hypertension, Tuberculosis, HIV- Immuno compromised patients.
- •Patients those who are not ready to give written consent.
结局指标
主要结局
To study the efficacy of Devdarvyadi Churna in the management of Vatashthila w.s.r to BPH
时间窗: 90 days study with | Follow-up on- 15th ,30th ,90th day
次要结局
- 1) To study the etiopathogenesis of Vatashthila w.s.r to BPH(2)To study the Literature of Devdarvyadi Churna)
研究者
Rushda Nazir Ahmed Karjikar
MES Ayurved Mahavidyalaya