A RANDOMIZED OPEN LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SPILANTHES ACMELLA MURR. SUPPOSITORY IN THE MANAGEMENT OF POST-OPERATIVE PAIN IN ANO-RECTAL SURGERIES WITH SPECIAL REFERENCE TO PARTIAL SPHINCTEROTOMY.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant reduction in post-operative pain
研究概览
简要总结
1)THIS STUDY HAS BEEN TAKEN UP TO TO EVALUATE THE EFFICACY OF SPILANTHES ACMELLA MURR. SUPPOSITORY IN THE MANAGEMENT OF POST-OPERATIVE PAIN IN ANO-RECTAL SURGERIES WITH SPECIAL REFERENCE TO PARTIAL SPHINCTEROTOMY
2)THE COMPARISION OF THE STUDY IS WITH DICLOFENAC SUPPOSITORY
3)HYPOTHESIS:-
NULL HYPOTHESIS :-
H0 :- There is no difference in the efficacy of Spilanthes acmella Murr. suppository and Diclofenac sodium suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial Sphincterotomy.
ALTERNATE HYPOTHESIS :-
H1 :- The efficacy of Spilanthes acmella Murr. suppository is better than Diclofenac sodium suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial Sphincterotomy.
H2 :- The efficacy of Diclofenac sodium suppository is better than Spilanthes acmella Murr. suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial sphincterotomy.
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
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with post-operative pain who underwent partial sphincterotomy under local anesthesia irrespective of gender, religion, occupation and socio-economic status will be randomly selected for study.
- •Subjects between age group of 21-60 years.
- •Subjects willing to give consent.
排除标准
- •Subjects with a known allergic reaction to Diclofenac sodium.
- •Subjects suffering from infectious diseases like HIV, Hepatitis and Tuberculosis.
- •Immunocompromised subjects.
结局指标
主要结局
Significant reduction in post-operative pain
时间窗: 3 DAYS
次要结局
- To improve the quality of life.[SF-36](- Generation of in-depth analyzed data on different aspect of the disease.)
研究者
Dr YASHASSU T KULOOR
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH