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

NCT ID: NCT02332486

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervene

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.

Group Type: ACTIVE_COMPARATOR

Qingxuan Decoction

Intervention Type: DRUG

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.

Blank

There is no intervention for people in the blank group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yang Xuyan

Deputy director of First Affiliated Hospital of Heilongjiang University of Chinese Medicine Department of Stomatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Xu Yan, Doctor

Role: PRINCIPAL_INVESTIGATOR

University of Chinese Medicine Department of Stomatology, Heilongjiang University of Chinese Medicine.

Central Contacts

Yang Xu Yan, Doctor

Role: CONTACT

444125750@qq.com

+86 0451-82193038

References

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Other Identifiers

81403441

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OLP-Metabonomics-2014

Identifier Type: -

Identifier Source: org_study_id