The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Changes in clinical response
研究概览
简要总结
IBD is a chronic disease with two major types of Crohn's Disease (CD) and Ulcerative Colitis (UC). Nowadays, synthetic drugs and monoclonal antibodies are the most common types of drugs used for IBD management. However, due to their side effects and the high relapse rate, many researchers are looking for plant-derived products to manage the disease. Saffron, Crocus sativus L., is widely used as spice and medicine with anti-obesity, anticonvulsant, anti-hyperlipidemic, anti-tumor, antioxidant, and anti-inflammatory properties. Besides, there is evidence of the favorable effects of saffron on the gut microbiome. The main aim of this proposal is to evaluate the effect of saffron as a complementary supplement or add-on therapy in combination with current therapeutic agents in patients with mild and moderate UC.
详细描述
This study will be a parallel, randomized, double-blinded clinical trial assessing the efficacy of the saffron extract compared to placebo in patients with mild and moderate UC. Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo. Randomization will be performed by an independent researcher (AAK) who is not directly involved in the trial and using software-generated random permuted blocks. Allocation concealment will be also conducted using sealed, opaque envelopes with consecutive numbering. The saffron and placebo will be provided free of charge by Sina Pajoohan Salamat co, Mashhad, Iran. The standard treatment will be administered to all patients as recommendations of the physicians.
Intervention
The intervention groups of study will be included:
- Mild UC patients, receiving100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
- Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
- Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
- Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
- Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
- Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
Demographic and baseline characteristics will be recorded, and assessment of anthropometric and biochemical parameters, fecal calprotectin, inflammatory cytokines, stool microbiome, and its transcriptomic, and metabolomic, urine and saliva metabolomics, health-related quality of life (HRQoL), anxiety, and disease severity will be done at baseline and after 8 weeks. Fecal calprotectin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and disease severity will also be evaluated at 4th week. Moreover, HRQoL and anxiety will also be examined after 6 and 12 months.
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)
盲法说明
Both patients and investigators do not know whether the participant receiving a placebo or saffron.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 18-80 years' old
- •Patients who have received a diagnosis of UC at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- •Patients with the ability to give written informed consent and to be compliant with the schedule of intervention and assessments
- •Patients with mild (3-5) or moderate (6-11) UC, according to the Simple Clinical Colitis Activity Index
排除标准
- •Pregnant patients or those planning pregnancy
- •Patients receiving immunosuppressive agents for diseases other than UC
- •Patients with confirmed cancer, dysplasia, autoimmune, and rheumatology diseases
- •Patients who had surgery for UC treatment
- •Individuals with liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) at the screening visit
- •Patients who have any condition affecting oral drug absorption.
- •Subjects with known active or untreated GI infections including C.diff, CMV, HSV, HIV
- •Subjects with clinical features of CD; history of CD (Crohns colitis, or Ileo-colitis), clinical signs of fulminant colitis, toxic megacolon, or Microscopic Colitis, indeterminate Colitis, infectious Colitis, or ischemic colitis
研究组 & 干预措施
Moderate UC-Saffron 100
Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
干预措施: Saffron 100 (Drug)
Mild UC-Saffron 100
Mild UC patients, receiving 100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
干预措施: Saffron 100 (Drug)
Mild UC-Saffron 50
Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
干预措施: Saffron 50 (Drug)
Moderate UC-Saffron 50
Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
干预措施: Saffron 50 (Drug)
Mild UC-placebo
Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
干预措施: Placebo (Drug)
Moderate UC-placebo
Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in clinical response
时间窗: 4 and 8 weeks
Changes in clinical response will be assessed by "Simple Clinical Colitis Activity Index", which has a total score between 0 to 19. Higher scores are interpreted to higher disease activity (worse outcome).
Changes in the fecal calprotectin level
时间窗: 4 and 8 weeks
Changes in the serum levels of CRP
时间窗: 4 and 8 weeks
Changes in the serum levels of ESR
时间窗: 4 and 8 weeks
次要结局
- Safety assessment (Incidence of Treatment-Emergent Adverse Events)(8 week)
- Changes in the serum anti-inflammatory and pro-inflammatory markers(8 week)
- Changes in the metabolomic profile of urine, stool, and saliva(8 weeks)
- Changes in the Health-related quality of life (HRQoL )(8, 24, and 48 weeks)
- Changes in the anxiety(8, 24, and 48 weeks)
- Changes in the stool microbiome and transcriptome(8 week)
研究者
Ali Reza Safarpour
Manager in chief of gastroenterohepatology research center, Assistant Professor
Shiraz University of Medical Sciences