Effect of Nano-curcumin Supplementation on Hospital Length of Stay, Clinical Outcomes,and Inflammation Level in Mild and Moderate Acute Pancreatitis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Hospital length of stay
研究概览
简要总结
This study aims to investigate the effect of nano-curcumin supplementation on hospital length of stay, clinical outcomes, and inflammation level in mild and moderate acute pancreatitis. 42 eligible patients with mild and moderate acute pancreatitis will randomly assign to consume two soft gels each containing 40 mg of nano-curcumin or placebo (control group) every morning and evening for two weeks. Both groups will also receive the standard medical treatment of acute pancreatitis according to relevant guidelines. Patient's blood samples and clinical outcomes will assess on days 0, 1, 2, 3, 4, and 14 of admission. The two groups will also be compared in terms of adverse events and hospital length of stay. Moreover, the patient's hospital readmission due to pancreatitis will be recorded within 90 days of hospitalization.
详细描述
The dietary intake of patients will be examined by two non-consecutive 24-hour food recalls at baseline and end of the study. The patient's weight (kg) and Body Mass Index (BMI) will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute pancreatitis by at least two of the three following criteria: 1) a history of acute abdominal pain 2) greater than the threefold elevation of the serum amylase and/or lipase level 3) computed tomographic evidence of acute pancreatitis
- •Admission within 72 hours of onset of pain
- •Age range of 18-75
- •Ability to intake soft gels orally
排除标准
- •Severe or critical AP on admission
- •Pregnancy or lactation
- •A history of allergy to curcumin
- •Acute exacerbation of chronic pancreatitis
- •Prior antioxidant therapy
- •Severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cr Cl < 30 ml/min))
- •Active infection
- •Active malignancy
- •Hyperthyroidism
- •Persistent organ failure > 48 hours (according to Marshall score)
- •On anticoagulant/ anti platelet medications
研究组 & 干预措施
Nano-curcumin
80mg of Nano-curcumin daily
干预措施: Nano-curcumin (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Hospital length of stay
时间窗: through study completion, up to 2 weeks
calculated from the day of admission until the time of discharge from the hospital.
次要结局
- Overall appetite(days 0, 1, 2, 3, 4, and 14 of admission)
- CRP(days 0 and 14 of admission)
- Hospital readmission(up to 90 days)
- Analgesic medications(days 0, 1, 2, 3, 4, and 14)
- Abdominal pain intensity(days 0, 1, 2, 3, 4, and 14 of admission)
研究者
Dr Azita Hekmatdoost
Professor
National Nutrition and Food Technology Institute