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

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qingxuan Decoction
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oral Lichen Planus

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervene

    Blank

    Arm Description

    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.

    There is no intervention for people in the blank group.

    Outcomes

    Primary Outcome Measures

    visualanalogue scale

    Secondary Outcome Measures

    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.
    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
    Biomarker
    Metabolites profiles of individual in the intervention group will be analysed by PCA、OPLS-DA or UPLC-MS.

    Full Information

    First Posted
    December 30, 2014
    Last Updated
    January 3, 2015
    Sponsor
    Heilongjiang University of Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02332486
    Brief Title
    Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study
    Acronym
    OLP
    Official Title
    Based on Metabonomics Dryness Pathogen Type of Oral Lichen Planus of Dynamic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Heilongjiang University of Chinese Medicine

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervene
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Blank
    Arm Type
    No Intervention
    Arm Description
    There is no intervention for people in the blank group.
    Intervention Type
    Drug
    Intervention Name(s)
    Qingxuan Decoction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    visualanalogue scale
    Time Frame
    every week of eight weeks
    Secondary Outcome Measure Information:
    Title
    Cytokines
    Description
    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.
    Time Frame
    every week of eight weeks
    Title
    Cytokines
    Description
    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
    Time Frame
    rvery week of eight weeks
    Title
    Biomarker
    Description
    Metabolites profiles of individual in the intervention group will be analysed by PCA、OPLS-DA or UPLC-MS.
    Time Frame
    every week of eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Xu Yan, Doctor
    Phone
    +86 0451-82193038
    Email
    444125750@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yang Xu Yan, Doctor
    Organizational Affiliation
    University of Chinese Medicine Department of Stomatology, Heilongjiang University of Chinese Medicine.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17822813
    Citation
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    Results Reference
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    PubMed Identifier
    3144585
    Citation
    Holmstrup P, Thorn JJ, Rindum J, Pindborg JJ. Malignant development of lichen planus-affected oral mucosa. J Oral Pathol. 1988 May;17(5):219-25. doi: 10.1111/j.1600-0714.1988.tb01528.x.
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    PubMed Identifier
    14662419
    Citation
    Gandolfo S, Richiardi L, Carrozzo M, Broccoletti R, Carbone M, Pagano M, Vestita C, Rosso S, Merletti F. Risk of oral squamous cell carcinoma in 402 patients with oral lichen planus: a follow-up study in an Italian population. Oral Oncol. 2004 Jan;40(1):77-83. doi: 10.1016/s1368-8375(03)00139-8.
    Results Reference
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    PubMed Identifier
    16128740
    Citation
    Chaiyarit P, Ma N, Hiraku Y, Pinlaor S, Yongvanit P, Jintakanon D, Murata M, Oikawa S, Kawanishi S. Nitrative and oxidative DNA damage in oral lichen planus in relation to human oral carcinogenesis. Cancer Sci. 2005 Sep;96(9):553-9. doi: 10.1111/j.1349-7006.2005.00096.x.
    Results Reference
    result
    PubMed Identifier
    15972624
    Citation
    Mosmann TR, Cherwinski H, Bond MW, Giedlin MA, Coffman RL. Two types of murine helper T cell clone. I. Definition according to profiles of lymphokine activities and secreted proteins. 1986. J Immunol. 2005 Jul 1;175(1):5-14. No abstract available.
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    PubMed Identifier
    23675060
    Citation
    Lee YC. Synergistic effect of various regulatory factors in TH1/TH2 balance; immunotherapeutic approaches in asthma. Int J Biomed Sci. 2008 Mar;4(1):8-13.
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    PubMed Identifier
    8600944
    Citation
    Krouwels FH, van der Heijden JF, Lutter R, van Neerven RJ, Jansen HM, Out TA. Glucocorticosteroids affect functions of airway- and blood-derived human T-cell clones, favoring the Th1 profile through two mechanisms. Am J Respir Cell Mol Biol. 1996 Apr;14(4):388-97. doi: 10.1165/ajrcmb.14.4.8600944.
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    Citation
    Agarwal SK, Marshall GD Jr. Dexamethasone promotes type 2 cytokine production primarily through inhibition of type 1 cytokines. J Interferon Cytokine Res. 2001 Mar;21(3):147-55. doi: 10.1089/107999001750133159.
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    PubMed Identifier
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    Citation
    van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.
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    Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study

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