An open labelled active controlled randomized comparative clinical study to evaluate the efficacy of standard ksharsutra & guggulu based Arshoghna mahakashaya ksharsutra in the management of Arsha w.s.r.to haemorrhoids
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- We will assess bleeding per rectum and
研究概览
简要总结
Arsha can be included as one of the lifestyle disorders caused due to sedentary lifestyle.the arsha is one among the ano-rectal disease which occurs in Gudapradesh(anus) as sadhyopranahara marma . Acharya Sushruta has mentioned several method of treatment .Among them Kshar sutra is mentioned in the treatment of arsha ,so I decided to evaluate the efficacy of standard Ksharsutra and gugglu based Arshoghna mahakashaya Ksharsutra in the management of arsha w s r to haemorrhoids .
Therefore i have selected this trial,there will be 80 patients in two groups and in each group will be 40 patients aged between 18 to 65 years,the patients should be selected on the basis of inclusion and exclusion criteria . We will assess bleeding per rectum and pain per anum in subjective parameters and swelling per anum and condition of anal sphincter tone in objective parameter . We will assess bleeding per rectum, pain in ano, swelling per anum and condition of anal sphincter at zero, 7th, and 14th day.
Follow up will be taken 21tn and 28th day.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of arsha attending the o.p.d and i.p.d of our ayurved hospital & Research institute.
- •diagnosed cases of 3rd degree and 4th degree interno-external pile mass Patient fit for operation.
排除标准
- •Pregnancy Rectal carcinoma Rectal prolapse Uncontrolled HT &DM Otherwise unfit for operation.
结局指标
主要结局
We will assess bleeding per rectum and
时间窗: We will assess bleeding per rectum and pain in ano at zerodays, 7thdays, and 14th day. follow up will be taken 21th and 28th day.
pain per anum.
时间窗: We will assess bleeding per rectum and pain in ano at zerodays, 7thdays, and 14th day. follow up will be taken 21th and 28th day.
次要结局
- we will assess swelling per anum and condition of anal sphincter tone.(we will assess swelling per anum and condition of anal sphincter tone at zero, 7th, and 14th day.)
研究者
Dr Ankit kumar gautam
OPD -3,Kunwar Shekhar Vijendra Ayurved Medical College and Research center,Gangoh,