A Randomized Control Clinical Trial To Evaluate The Efficacy Of Aragvadha Pratisarniya Kshara In The Management Of Gudaarsha (Haemorrhoids)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) effect of Pratisarniya Aragvadha kshar on Gudaarsha
研究概览
简要总结
Title A Randomized Control Clinical Trial to evaluate the efficacy of aragvadha pratisarniya Kshara in the management of Gudaarsha (haemorrhoids)
Null hypothesis H0 - Aragvadha Pratisarniya Kshara Is Not Effective in the management of Gudaarsha
Alternate Hypothesis H1 -Aragvadha Pratisarniya Kshara Is Effective in the management of Gudaarsha
Study Design -Simple Randomized Control Clinical Trial
Inclusive Criteria -
Patients with clinical signs and symptoms of Gudaarsha,
Patients of Gudaarsha under age group of 20 to 60 years of age irrespective of gender , patients with 2nd 3rd 4th degree piles
Exclusive Criteria -
Patients with 1st degree piles, patients with other comorbid conditions, patients below 20 yrs and above 60yrs, pregnancy and other surgical indications , patients with malignancy HIV HBSAG , patients with bleeding piles
Sample size-60
Group A
Aragvadha Pratisarniya Kshara application on 1st 7th 15th day with follow up on 1st 7th 15th day
Group B
Kankayan vati 500mg BID with koshna jaala pashchatbhakt
Abhayarishta 15ml BID with koshna jaala pashchatbhakt
Total Duration of the Study 15 days
Follow up on 1st 7th 15th day
Mode of application of therapy - local application
Assessment criteria
Objective - number of pile mass , size of pile mass
Subjective - pain in ano , constipation, itching ,per rectal bleeding
Results will be drawn based on assessment criteria and 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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinical signs and symptoms of Gudaarsha 2) Patients of 20 – 60 years age groups, irrespective of sex.
- •Patients with piles 2 nd 3 rd and 4th degree piles.
排除标准
- •Patients with 1 st degree piles 2) Patients with other co-morbid condition and other systemic pathology and other local lesion.
- •Patients with pregnancy and surgical indications 4) More than 60 years and less than 20 years patients.
- •Patients having malignancy, HIV, HBsAG.
- •Patients having severe bleeding piles.
结局指标
主要结局
1) effect of Pratisarniya Aragvadha kshar on Gudaarsha
时间窗: 15 days study with application of kshar karma once a week with follow up on 1st 7th 15th day
2) changes in the clinical features of patients of Gudaarsha
时间窗: 15 days study with application of kshar karma once a week with follow up on 1st 7th 15th day
次要结局
- 1.To evaluate the methodology of pratisarniya kshar.(2. To evaluate the properties argavadha pratisarniya kshar.)
研究者
Dr Kapil Vitthal Rathod
MES Ayurved Mahavidyalaya