RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- endoscopic remission
研究概览
简要总结
Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.
详细描述
44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).
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
- Single (Participant)
盲法说明
22 patients were assigned to Group-A (5-ASA oral 800mg x 3 / day + 1 enema 60ml Aloe Vera gel / day) and 22 patients to Group-B (5-ASA oral 800mg x 3 / day + enema 60ml 1 Placebo / day).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease.
排除标准
- •an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance
研究组 & 干预措施
22 patients were assigned to Group-A
22 patients were assigned to Group-A
干预措施: Aloe vera gel (Drug)
22 patients were assigned to Group-B
22 patients were assigned to Group-B
干预措施: Aloe vera gel (Drug)
结局指标
主要结局
endoscopic remission
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Roberta Pica
MD, PhD
Ospedale Sandro Pertini, Roma