ITMCTR2100004776招募中未知
Screening Targets for Damp-Heat Syndrome of Inflammatory Bowel Disease-Based on Untargeted Metabolomics to Explore Substantial Basis of Damp-Heat Syndrome in Immune Mediated Enteropathy and Effective Mechanism of Active Components from Paris Polyhoylla var. Chinensis
Affiliated Hospital of Nanjing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. Inclusion criteria for inflammatory bowel disease.
- •(1) It is consistent with the diagnosis of active ulcerative colitis (or Crohn's disease), including the current use of mesalazine (or suppositories), the use of Chinese medicine preparations (or Chinese medicine enema), probiotic preparations (live bifidobacteria or triple live bacteria of bifidobacteria or live bacteria of Bacillus subtilis), and enteral nutrition powder.
- •(2) The syndrome differentiation of Chinese medicine is the syndrome of internal accumulation of dampness and heat or spleen deficiency syndrome.
- •(3) The age is from 18 to 75 years old, regardless of gender.
- •(4) Those who voluntarily participate in the clinical study and sign the informed consent form.
- •2.Inclusion criteria for celiac disease.
- •(1) It meets the diagnostic criteria of celiac disease.
- •(2) The syndrome differentiation of Chinese medicine is spleen deficiency syndrome.
- •(3) Aged 18 to 75 years, regardless of gender.
- •(4) Those who voluntarily participate in the clinical trial and sign the informed consent form.
- •3. Inclusion criteria of functional diarrhea.
- •(1) It meets the diagnostic criteria of functional diarrhea.
- •(2) The syndrome differentiation of Chinese medicine is spleen deficiency syndrome.
- •(3) The age is from 18 to 75 years old, regardless of gender.
- •(4) Those who voluntarily participate in clinical trials and sign informed consent forms.
- •4. Inclusion criteria for healthy persons.
- •(1) No history of circulatory, respiratory, digestive or urinary diseases.
- •(2) Blood, urine, fecal routine, liver and kidney function, electrocardiogram, ultrasound liver, gallbladder, spleen and pancreas, whole chest X-ray were normal, and routine physical examination of surgery, facial features and gynecology (female) were normal. The tongue is reddish and the fur is thin and white.
- •(3) Aged 18 to 75 years, regardless of gender.
- •(4) Those who voluntarily participate in the clinical trial and sign the informed consent form.
排除标准
- •1. Patients with IBD are in remission or are using hormone, infliximab and other biological agents, azathioprine, thalidomide and other immune agents.
- •2. Patients with intestinal organic lesions and serious complications, such as local stricture, intestinal obstruction, intestinal perforation, malignant polyps, toxic colonic dilatation, colon cancer, rectal cancer, or other anal diseases affect drug evaluation.
- •3. Infectious colitis such as bacillary dysentery, intestinal tuberculosis, amoebic dysentery, chronic schistosomiasis and diarrhea caused by ischemic colitis, radiation colitis, parasitic infection, metabolic diseases, etc.
- •4. Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system (such as primary hepatocellular carcinoma, melanoma, leukemia, lymphoma, myeloproliferative disease, Addison's disease, primary nephrotic syndrome, etc.) and mental illness.
- •5. Women who are pregnant or planning pregnancy, lactating women, patients of childbearing age who are unable or unwilling to use adequate contraception during the trial, or whose spouses are unwilling to use contraception.
- •6. According to the judgment of the researcher, it is not suitable to participate in this researcher.
研究者
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