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临床试验/NCT02332486
NCT02332486Unknown不适用

Based on Metabonomics Dryness Pathogen Type of Oral Lichen Planus of Dynamic

Heilongjiang University of Chinese Medicine0 个研究点目标入组 25 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
25
主要终点
visualanalogue scale

研究概览

简要总结

Due to the change of life style, the incidence of oral cavity mucous membrane disease increased.In this study,been done a large number of pre-clinical practice and some experimental studies, based on the application of metabolomics technology to ultra-high liquid-mass spectrometry metabolomics analyzer as the core means, The metabolism of pattern recognition and combination of modern analytical techniques to measure blood and urine of patients with OLP-specific clearance of endogenous metabolites,and after the intervention of moss drink endogenous metabolites in the body as a whole group of. At the same time, the use of flow cytometry,,ELISA, immunohistochemistry and other modern technology, research OLP patients using clean moss drink before and after treatment of local lesions and peripheral blood CD4 +,CD8 + lymphocytes,Th1 cytokines (IFN-γ, TNF-α), Th2 cytokines (IL-4,10) the dynamic changes. From metabolomics, cellular immunology, inflammation mechanism perspective of local OLP lesions, peripheral blood and changes in endogenous metabolites in the process,,in-depth study of traditional Chinese medicine to drink clean moss multi-component multi-target treatment of this disease mechanism, is widely used in traditional Chinese medicine treatment of OLP provide a theoretical basis for the promotion of Chinese medicine Qingxian Yin in the oral mucosal disease in the application, effectively solve clinical practice problems.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with OLP .
  • TCM syndrome of OLP patients included is dryness pathogen type.
  • In the lesions of oral mucosa there are phanerous pearly white keratinization stripes, or patches, or phanerous erosion with the mucous membrane hyperemia.
  • OLP patients may accompany oral coarse discomfort or pain, red tongue, yellow dry or dry fur, dry mouth, bitter taste.

排除标准

  • Patients with other established oral mucosal disease;
  • Patients accompanied by serious systemic diseases, eg damaged liver or kidney functions; Or other allergic diseases, eg rheumatic disease or cancer.
  • Patients using the antibiotic in the last one month or immunologic agents in the last three months.
  • Lichenoid reaction caused by drugs or the filling with silver and amalgam.
  • Patients with smoking or alcoholism in the last three months.

研究组 & 干预措施

Intervene

Active Comparator

For Qingxuan Decoction there are a bag of Chinese honeylocust spine,Glehnia littoralis and Smilax china L,and two bags of Silktree albizia bark, Kadsura interior,Cortex dictamni, Lilium brownii var, Silkworm larva,Forsythia suspensa and Rhizoma polygonati preparata, and three bags of viridulumArisaema erubescens and Poria cocos Wolf. All drugs are made by Jiangyin Tianjiang company in China. Qingxuan Decoction is given two times after breakfast and dinner in 56 days.

干预措施: Qingxuan Decoction (Drug)

结局指标

主要结局

visualanalogue scale

时间窗: every week of eight weeks

次要结局

  • Cytokines(rvery week of eight weeks)
  • Biomarker(every week of eight weeks)

研究者

发起方
Heilongjiang University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Xuyan

Deputy director of First Affiliated Hospital of Heilongjiang University of Chinese Medicine Department of Stomatology

Heilongjiang University of Chinese Medicine

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