Clinical Study of Vitamin B5 in Adjuvant Treatment of Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.
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
- •Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI:10.19538/j.nk2018090106);
- •Have complete medical history data;
- •Volunteer to participate in this clinical trial and sign the informed consent form.
排除标准
- •Hemophilic patients;
- •There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
- •Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases;
- •Take calcium pantothenate preparation in recent 3 months;
- •Have a history of abuse of psychoactive substances;
- •Pregnant or lactating women, or plan to be pregnant in the next 6 months;
- •Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease;
- •Participate in other clinical trials in the past 6 months;
- •Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)
研究组 & 干预措施
Vitamin B5 group
Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.
干预措施: Vitamin B5 Tablets (Drug)
Control group
Based on the standard IBD treatment, the same type of placebo tablets are given orally three times a day, four tablets each time, for 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Clinical remission rate
时间窗: Through study completion, an average of 12 months.
To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAI score\<150) in IBD patients after 12 weeks of oral Vitamin B5 while taking routine treatment.
次要结局
- Disease activity score of IBD patients(Through study completion, an average of 12 months.)
- Histological remission(Through study completion, an average of 12 months.)
- Clinical response(Through study completion, an average of 12 months.)
研究者
Zhaoshen Li
Director of gastroenterology department
Changhai Hospital