Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Qingxuan Decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervene<br>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. | Drug: Qingxuan Decoction<br>* In 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.<br>|
| No Intervention: Blank<br>There is no intervention for people in the blank group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visualanalogue scale |  | every week of eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines | IFN-γ, TNF-α, IL-4 and IL-10 of the blood cells of CD4+/CD8+ and Th1/Th2 will be tested by flow cytometry or ELISA. | every week of eight weeks | 
| Cytokines | IFN-γ, TNF-α, IL-4 and IL-10 of the lesion tissue cells of CD4+/CD8+ and Th1/Th2 will be tested by immunohistochemistry | rvery week of eight weeks | 
| Biomarker | Metabolites profiles of individual in the intervention group will be analysed by PCA、OPLS-DA or UPLC-MS. | every week of eight weeks |