Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Full Mayo Score
研究概览
简要总结
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis by histopathology of Ulcerative Colitis with mild activity level clinical, Endoscopic and histological.
- •Extent of disease: pancolitis, ulcerative proctitis and left.
- •Being treated with 5 - aminosalicylates (5-ASA).
- •Belonging to the National Institute of Medical Sciences and Nutrition "Salvador Zubirán".
- •Signed informed consent.
排除标准
- •Autoimmune diseases (lupus, HIV, cancer and any hepatitis).
- •Another type of colitis (indeterminate, infectious drug and Crohn's Disease.
- •Previous total colectomy.
- •Body mass index less than 19.9 kg/m2 or greater than 40 kg/m
- •Patients in remission histology, clinical and endoscopic.
- •Under treatment with steroids, azathioprine, diuretics and anticoagulants.
- •Use Aloe Vera or some natural therapy.
结局指标
主要结局
Full Mayo Score
时间窗: 3 months
Interleukine - 6
时间窗: 3 months
Quantification in mucosal Biopsy
次要结局
未报告次要终点
研究者
Jesús Kazuo Yamamoto Furusho
MD PhD
National Institute of Medical Sciences and Nutrition, Salvador Zubiran