An investigator initiated prospective single arm open-label study to evaluate effectiveness of Camylofin 50 mg and Paracetamol 325mg in patients with acute colicky abdominal pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOS
研究概览
简要总结
Acute colicky abdominal pain is sudden severe localised urinary or gastrointestinal pain that is usually abrupt and spasm like Evidence suggests that analgesic spasmolytic and anticholinergic agents play supportive roles in relieving pain and symptoms in patients with acute colicky abdominal pain Although there is enough evidence of the effectiveness and safety of Camylofin with other NSAIDs like paracetamol (also called acetaminophen) nimesulide diclofenac and mefenamic acid data on the effectiveness of FDC of Camylofin 50 mg with Paracetamol 325 mg is lacking
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects aged 18 65 years Patients attending OPD with acute colicky abdominal pain and having at least one episode of colicky pain within 24 hours prior to the visit Non complicated cases of acute colicky abdominal pain may be confirmed by imaging tests such as Ultrasound Sonography USG performed prior to the treatment initiation to ensure no complicated cases get recruited as perwill be performed at the discretion of the investigator Patient willing to provide written informed consent to will be enrolled in the study.
排除标准
- •Patients with history of hypersensitivity to the study drugs any of study drugs ingredients Patients who had undergone coronary artery bypass graft surgery with epilepsy or inflammatory bowel disease will be excluded Patients with chronic abdominal pain such as Celiac disease lactose intolerance ulcerative colitis and Crohns disease Patients who may have narrow angle glaucoma mechanical stenosis Pregnancy and lactation Urinary retention Mega colon GI hemorrhage Tachyarrhythmia Porphyria Patients with any other conditions or diseases that investigator considers as ineligible to enroll in the study based on approved prescribing information.
结局指标
主要结局
Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOS
时间窗: Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOS
次要结局
- To assess how much time it takes on average for people to feel relief from pain by looking at a ten point reduction in the pain intensity score on the visual analogue scale(To assess how much time it takes on average for people to feel relief from pain by looking at a ten point reduction in the pain intensity score on the visual analogue scale)
研究者
Dr Chandravati
Krishna Medical Center