The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm
研究概览
简要总结
Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. Several studies have proven that curcumin has well-established anti-inflammatory properties. However, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. The investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have mild to moderate ulcerative colitis, with a current Partial Mayo Index greater than or equal to 2 and less than or equal to 6
- •Age 18 years and above
- •Male or female
- •Patients who have given consent and area able to follow the treatment given
- •Patients who are able to record their responses in survey form at regular follow-up visits
排除标准
- •Patients who are in remission from ulcerative colitis, or who have a Partial Mayo Index Score of 0 or 1
- •Patients who have been taking azathioprine or mercaptopurine for <12 weeks for the treatment of their ulcerative colitis
- •Patients who are taking steroids or biologic agents for the treatment of their ulcerative colitis
- •Patients who have severe ulcerative colitis, or who have a Partial Mayo Index Score of 7 or above
- •Patients who are noncompliant with medication or regular follow up visits
- •Patients who are unable to or unwilling to record their responses in survey form
- •Patients with comorbid illnesses, including: Diabetes Mellitus, Stage III or above Congestive Heart Failure, chronic pancreatitis, severe liver or renal disease
- •Patients who have current gallstones or any biliary dysfunction
- •Patients with anemia (Hemoglobin <10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
- •Patients who currently have an ongoing severe infection/sepsis
- •Patients with a history of malignancy
- •Patients who are currently pregnant or nursing
- •Patients who are current smokers
研究组 & 干预措施
Treatment Arm
Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen:
Starting dose: 50 mg BID of Bio-enhanced Curcumin Soft Gelatin Capsule Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug
干预措施: Bio-enhanced Curcumin Soft Gelatin Capsule (Dietary Supplement)
Treatment Arm
Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen:
Starting dose: 50 mg BID of Bio-enhanced Curcumin Soft Gelatin Capsule Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug
干预措施: 5-Aminosalicylic acid (Drug)
Control Arm
Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals
干预措施: 5-Aminosalicylic acid (Drug)
结局指标
主要结局
Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm
时间窗: 1 year
Clinical remission is recorded by a Partial Mayo Index score of 0-1
Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm
时间窗: 1 year
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of \<3
次要结局
- Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control arm(1 year)
研究者
Rupa Banerjee
Consultant Gastroenterologist; Director, IBD Clinic
Asian Institute of Gastroenterology, India