Oral Lichen PlanusOLPNCT02332486
Based on Metabonomics Dryness Pathogen Type of OLP: a Dynamic Study
A study testing Qingxuan Decoction in people with Oral Lichen Planus, run by Heilongjiang University of Chinese Medicine.
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… Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Qingxuan Decoction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Based on Metabonomics Dryness Pathogen Type of Oral Lichen Planus of Dynamic
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
- Being tested
- Qingxuan Decoction
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingxuan DecoctionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervene | Active comparator | 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. Receives: Drug: Qingxuan Decoction |
| Blank | No intervention | There is no intervention for people in the blank group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visualanalogue scale
Measured: every week of eight weeks
Secondary outcomes (3)
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.
Measured: every week of eight weeks
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
Measured: rvery week of eight weeks
Biomarker
Metabolites profiles of individual in the intervention group will be analysed by PCA、OPLS-DA or UPLC-MS.
Measured: every week of eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xuyan, Heilongjiang University of Chinese Medicine
- Investigators
- Yang Xu Yan, Doctor, Principal investigator, University of Chinese Medicine Department of Stomatology, Heilongjiang University of Chinese Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332486
- Sponsor's protocol ID
- OLP-Metabonomics-2014
- Other IDs
- 81403441
- Acronym
- OLP
- Status last verified
- Jan 2015
- First submitted
- 30 Dec 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
Publications
Scully C, Carrozzo M. Oral mucosal disease: Lichen planus. Br J Oral Maxillofac Surg. 2008 Jan;46(1):15-21. doi: 10.1016/j.bjoms.2007.07.199. Epub 2007 Sep 5.
PubMed 17822813Holmstrup 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.
PubMed 3144585Gandolfo 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.
PubMed 14662419Chaiyarit 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.
PubMed 16128740Mosmann 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.
PubMed 15972624Lee 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.
PubMed 23675060Krouwels 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.
PubMed 8600944Agarwal 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.
PubMed 11331037van 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.
PubMed 12969224Mendoza L. A network model for the control of the differentiation process in Th cells. Biosystems. 2006 May;84(2):101-14. doi: 10.1016/j.biosystems.2005.10.004. Epub 2005 Dec 28.
PubMed 16386358
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on Metabonomics Dryness Pathogen Type of Oral Lichen Planus of Dynamic
- ClinicalTrials.gov ID
- NCT02332486
- Acronym / sponsor ID
- OLP / OLP-Metabonomics-2014
- Conditions
- Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervene | Active comparator | Drug: Qingxuan DecoctionFor 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. |
| Blank | No intervention | –There is no intervention for people in the blank group. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qingxuan DecoctionIn 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. | Drug | Intervene |
Primary outcome
visualanalogue scale
Time frame: every week of eight weeks
3 secondary outcomes
Cytokines
Time frame: every week of eight weeks
Cytokines
Time frame: rvery week of eight weeks
Biomarker
Time frame: every week of eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Results publication: PubMed 17822813Scully C, Carrozzo M. Oral mucosal disease: Lichen planus. Br J Oral Maxillofac Surg. 2008 Jan;46(1):15-21. doi: 10.1016/j.bjoms.2007.07.199. Epub 2007 Sep 5.
- Results publication: PubMed 3144585Holmstrup 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.
- Results publication: PubMed 14662419Gandolfo 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 publication: PubMed 16128740Chaiyarit 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 publication: PubMed 15972624Mosmann 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.
- Results publication: PubMed 23675060Lee 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.
- Results publication: PubMed 8600944Krouwels 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.
- Results publication: PubMed 11331037Agarwal 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.
- Results publication: PubMed 12969224van 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.
- Results publication: PubMed 16386358Mendoza L. A network model for the control of the differentiation process in Th cells. Biosystems. 2006 May;84(2):101-14. doi: 10.1016/j.biosystems.2005.10.004. Epub 2005 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Xu Yan, Doctor principal investigator
University of Chinese Medicine Department of Stomatology, Heilongjiang University of Chinese Medicine.
Questions about this trial
What is this clinical trial studying?
A study testing Qingxuan Decoction in people with Oral Lichen Planus, run by Heilongjiang University of Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xu Yan, Doctor (+86 0451-82193038, 444125750@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visualanalogue scale (time frame: every week of eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332486, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.