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

Oral Lichen Planus Clinical Trial

— OLP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02332486
• Other study ID #: OLP-Metabonomics-2014
• Secondary ID: 81403441
• Status: Not yet recruiting
• Phase: N/A
• First received: December 30, 2014
• Last updated: January 3, 2015
• Start date: January 2015

Study information

• Verified date: January 2015
• Source: Heilongjiang University of Chinese Medicine
• Contact: Yang Xu Yan, Doctor
• Phone: +86 0451-82193038
• Email: 444125750[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethic Committee of First Affiliated Hospital of Heilongjiang University of Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Qingxuan Decoction
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

References & Publications (10)

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. — View 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. — View 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):7 — View 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. — View 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 — View 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. — View Citation

Mendoza L. A network model for the control of the differentiation process in Th cells. Biosystems. 2006 May;84(2):101-14. Epub 2005 Dec 28. — View 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. — View Citation

Scully C, Carrozzo M. Oral mucosal disease: Lichen planus. Br J Oral Maxillofac Surg. 2008 Jan;46(1):15-21. Epub 2007 Sep 5. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visualanalogue scale		every week of eight weeks	No
Secondary	Cytokines	IFN-?, TNF-a, 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	No
Secondary	Cytokines	IFN-?, TNF-a, 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	No
Secondary	Biomarker	Metabolites profiles of individual in the intervention group will be analysed by PCA?OPLS-DA or UPLC-MS.	every week of eight weeks	No