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
About this trial
This is an interventional basic science trial for Oral Lichen Planus
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.
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
NCT ID
NCT02332486
First Posted
December 30, 2014
Last Updated
January 3, 2015
Sponsor
Heilongjiang University of Chinese Medicine
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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Citation
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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.
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PubMed Identifier
16128740
Citation
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PubMed Identifier
15972624
Citation
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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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Citation
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Results Reference
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Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study
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