Randomized comparative clinical study to evaluate efficacy of Sirisha caplet with Diclofenac suppository in the management of post-operative pain in lower abdomen surgeries.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sirisha caplet is effective in post-operative pain management as a rectal analgesic. Pain assessment done by VAS scale.
研究概览
简要总结
| Randomized controlled clinical study to evaluate efficacy of Sirisha caplet with Diclofenac suppository in the management of post-operative pain. |
| There are Paracetamol and Diclofenac suppository are available and working moderately. These drugs are having adverse effect like rectal bleeding, rectal ulceration etc. An ultimate goal of surgical treatment is approaching better recovery for a high quality of life without complications and squeals. In NBM Patients rectal administration of drugs having advantages. The rectal route may represent a practical alternative and rectal administration is now well accepted for delivering, for example, anticonvulsants, non-narcotic and narcotic analgesics, theophylline, antiemetics and antibacterial agents, and for inducing anaesthesia |
Some medications can be inserted into anus (rectal) as a suppository. They may contain active ingredients that have a local effect. Rectal administration provides rapid absorption of many drug and easy alternative to Intramuscular/Intravenous route. It is a painless procedure the most important consideration are slow onset of disintegration (minutes) absorption of medicine and the prolonged duration of effect (analgesic) in rectal route.
This study plan to access efficacy of sirisha caplet in the management of post operative pain.
sample size 60
Duration 03 Days
Administration sirisha caplet 1gram per rectally
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •60 Patients will be taken in age group of 18-50 irrespective of gender.
- •Post operative patient who have been operated for lower abdomen surgeries includes ilio-inguinal surgeries, Ano-rectal surgeries, pelvic floor surgeries and surgeries related to genital region.
排除标准
- •Patients who suffers from diarrhoea, Acute fissure, Active P/R Bleeding.
- •CA rectum, Tuberculosis of abdomen, Dysentery.
结局指标
主要结局
Sirisha caplet is effective in post-operative pain management as a rectal analgesic. Pain assessment done by VAS scale.
时间窗: 03 Days
次要结局
- Sirisha caplet is less/equal/more effective than Diclofenac suppository in post-operative pain management. Pain assessment done as per VAS scale.(03 Days)
