The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 50% improvement of the Clinical Activity Index (CAI) of the study.
研究概览
简要总结
The aim of the study is to reduce the severity and duration of acute attacks, to prevent the recurrence of new acute attacks and to improve patient's quality of life.
Coltect contains anti inflammatory and antioxidant natural agents (curcumin, green tea and selenomethionine) which are associated with a positive effect on inflammatory disease.
The investigators assume that Coltect represents a tolerable and mild treatment, viable alternative to other medical therapies with fewer side effects.
Coltect is a food supplement that contains active ingredients from herbal sources.
详细描述
Studies in animal models of colitis and in humans with IBD demonstrated that the components of Coltect have anti-inflammatory effects:
Hanai H. et al demonstrated that curcumin was safe and effective in maintaining remission in patients with quiescent UC. (7)
B.Salh et al showed that curcumin, was able to attenuate colitis in the dinitrobenzene sulfonic acid (DNB)-induced murine model of colitis. The immunohistochemical signal is dramatically attenuated at the level of the mucosa by curcumin. The authors thus proposed that curcumin may have therapeutic implications for human IBD. (8)
Potential Benefits of Coltect- Coltect might be suited for the treatment of patients with mild to moderate flare-ups of ulcerative colitis.
Coltect provides an effect with expected low incidence of side effects. (each agent tested before and found safe for human use).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-75 years old.
- •Subjects with mild to moderate active ulcerative colitis
- •Hemoglobin value greater than 10 g/dL.
- •Aspartate aminotransferase and alanine aminotransferase <1.5 times the upper limit of normal.
- •Serum bilirubin and creatinine <1.5 × upper limit of normal.
- •Subjects that provided informed consent and agree to comply with all study procedure.
- •Subjects had a Clinical Activity Index (CAI) >4
- •Subjects had a Clinical Activity Index (CAI) ≤8
- •Established or new diagnosis.
- •Subjects that agreed to undergo sigmoidoscopy at study completion
排除标准
- •Active chronic inflammatory or autoimmune disease other than UC.
- •Active infection, including viral infection.
- •Active peptic ulcer disease.
- •Infectious/ Ischemic colitis.
- •Acute or chronic cardiac, renal failure (serum creatinine >300 mmol/L)
- •Abnormal liver function - (liver function tests greater than 1.5 times upper range of normal).
- •Crohn's disease.
- •Use of rectal corticosteroids within 4 weeks before study entry.
- •Patients with known or suspected bleeding tendency.
- •Patients with severe active ulcerative colitis.
- •Present or a history of colorectal cancer.
- •Serious other disease(s) that according to physicians judgment should preclude the patient from participation in the study.
- •Toxic megacolon.
- •Prior bowel resection.
- •Baseline positive stool culture or C DIFF toxin assay.
- •Existing or intended pregnancy.
研究组 & 干预措施
Coltect
Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.
干预措施: Coltect (Dietary Supplement)
结局指标
主要结局
50% improvement of the Clinical Activity Index (CAI) of the study.
时间窗: 2 months
次要结局
未报告次要终点