CTRI/2017/05/008449已完成4 期
Efficacy and safety of fixed dose combination of drotaverine hydrochloride(80 mg)and paracetamol(500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: a double blind randomized controlled trial
Walter Bushnell Pvt Ltd1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2015年5月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mean pain intensity difference (PID) assessed by VAS at 60 minutes after administration of study medication.
研究概览
简要总结
The study will be done in adults between ages of 18-59 years. Participants will either receive combination of drotaverine hydrochloride and paracetamol or only paracetamol for three days. Participants will be evaluated at time of enrolment and then after first dose of drug for 120 minutes to assess abdominal pain relief .Follow up shall be after three days. All adverse events will be recorded.Results have not been finalised yet as recruitment has just completed and data is being processed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between 18 to 59 years of either gender with presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft, stools accompanied by symptoms within 24 hours preceding randomization with duration of illness ≤ 72 hours) who present with moderate to severe (baseline pain intensity [PI] score on a 100-mm visual analog scale [VAS] of > 50 mm and “moderate to severe†on a VRS scale) abdominal pain present at enrollment.
- •2.Patients who give written informed consent with videography prior to the study entry.
- •3.Patients with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator.
排除标准
- •1.Patients with moderate or severe dehydration requiring hospitalization and administration of intravenous medications.
- •2.Patients with bloody diarrhoea and dysentery.
- •3.Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation.
- •4.Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants).
- •5.Patients with other established etiologies as pancreatitis, inflammatory bowel disease (IBD) or irritable bowel disease (IBS), previous gastrointestinal surgery and known immunodeficiency.
- •6.Patients with history of hypersensitivity to paracetamol and/or drotaverine.
- •7.Patients taking opioid analgesics, NSAIDs, and sedatives in the last 24 hours.
- •8.Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, diabetes, hypertension, hypo or hyperthyroidism.
- •9.Pregnant & lactating women.
- •10.Patients participating in any other clinical trial.
结局指标
主要结局
Mean pain intensity difference (PID) assessed by VAS at 60 minutes after administration of study medication.
时间窗: 30 minutes, 45 minutes and 60 minutes
2.PI assessed through VAS scores/ Total pain relief (TOTPAR), the summed, time-weighted pain relief ar 2 h using both VAS and VRS data [TOTPAR 2 (VAS) and TOTPAR 2 (VRS)].
时间窗: 30 minutes, 45 minutes and 60 minutes
次要结局
- Onset of pain relief (Onset of pain relief will be defined as pain relief score or PID of less than 30 for 30 minutes with VAS; pain relief score or pain intensity difference of 1 on VRS).(2. Number of episodes of pain/spasm, stool frequency and vomiting during 3 days of use of drug.)
研究者
研究点 (1)
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