Clinical trial NCT02332486: Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study
Official title: Based on Metabonomics Dryness Pathogen Type of Oral Lichen Planus of Dynamic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Lichen Planus
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: visualanalogue scale
timeFrame: every week of eight weeks
Secondary outcomes:
measure: Cytokines
timeFrame: every week of eight weeks
measure: Cytokines
timeFrame: rvery week of eight weeks
measure: Biomarker
timeFrame: every week of eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Chinese Medicine Department of Stomatology, Heilongjiang University of Chinese Medicine.
name: Yang Xu Yan, Doctor
role: PRINCIPAL_INVESTIGATOR
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