Efficacy of Purslane in Treatment of Oral Lichen Planus
September 7, 2010 updated by: Qazvin University Of Medical Sciences
Treatment of Oral Lichen Planus Lesions
Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous remission.
Patients with OLP had significantly increased risk of oral squamous cell carcinoma, irrespective of the clinical type of OLP and therapy.
there is currently no cure for OLP.
Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids.DNA and proteins in lichen planus.
This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction.
Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties.
The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Oral lichen planus is a chronic common inflammatory disorder affecting stratified squamous epithelia.
The majority problem of OLP is development of oral squamous cell carcinoma , irrespective of the clinical type of OLP and therapy.
Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids, DNA and proteins in lichen planus .This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction.
So oxidative stress could be effective in pathogenesis of OLP.
Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties.
Purslane also decreased the level of TNF-α and IL6, that are responsible for up-regulated adhesion molecules (in OLP lymphocyte T (T cell) recruited and retained in sub mucosa through receptors to endothelial adhesion molecule.
and basal keratinocytes undergo apoptosis).
The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Qazvin, Iran, Islamic Republic of, 3415759811
- Qazvin University of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in combination with clinical appearance will be used for diagnosis
- Patients who had symptoms such as burning sensation, pain
- Patients not on any immunosuppressive or immunomodulatory treatment. In case they were,then such treatment should be stopped and a washout period of 1 month was given.
- Patients of both sexes between 30 to 70 year's old
- Patients who gave written informed consent
- Patients who were willing for evaluation in second week after therapy and every 1 month up to 6 months
Exclusion Criteria:
- The presence of histological signs of dysplasia
- Patients suffering from any localized or systemic disease
- Renal disease patients
- Pregnant patients
- Patients who can not continue the study for private or social reasons
- Patients who used lichenoid reaction including drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Patients with oral lichen planus
|
Patients had been clinically with OLP and confirmed by histopathological findings were selected for the study.
Gender, age, medical history, symptoms, types, size, and site of the lesions , duration of disease and other treatment used for this disease were recorded.
Local ethical committee approval was obtained before the trial started and all patients gave written informed consent.
Patients were randomly divided into two groups .First group received systemic Purslane CAP with concentration antioxidant 235 mg/day in 1 dosage and second group used placebo CAP for 3 month.
Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and every 1 month up to 6 months
Other Names:
|
|
Placebo Comparator: 2
Patients with oral lichen planus
|
Patients had been clinically with OLP and confirmed by histopathological findings were selected for the study.
Gender, age, medical history, symptoms, types, size, and site of the lesions , duration of disease and other treatment used for this disease were recorded.
Local ethical committee approval was obtained before the trial started and all patients gave written informed consent.
Patients were randomly divided into two groups .First group received systemic Purslane CAP with concentration antioxidant 235 mg/day in 1 dosage and second group used placebo CAP for 3 month.
Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and every 1 month up to 6 months .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relief sign &symptom and clinical features
Time Frame: (every 1 month up to 6months)
|
(every 1 month up to 6months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relief sign &symptom and clinical features
Time Frame: (time frame6 months)
|
(time frame6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: farzaneh aghahosseini, professor, Tehran University of Medical Sciences
- Study Director: farzaneh aghahosseini, professor, Tehran University of Medical Sciences
- Study Director: hamidreza monsef esfehani, PHD, Tehran University of Medical Sciences
- Study Director: Katayun Borhanmojabi, DDS-MS, Qazvin University of Medical Sciences
- Study Director: Shahroo Etemad moghadam, DDS-MS, Qazvin University of Medical Sciences
- Principal Investigator: Aida(touba) Karagah, DDS, Qazvin University of Medical Sciences
- Study Director: Eraj mirzaii, physiology, Tehran University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
September 2, 2008
First Submitted That Met QC Criteria
September 3, 2008
First Posted (Estimate)
September 4, 2008
Study Record Updates
Last Update Posted (Estimate)
September 8, 2010
Last Update Submitted That Met QC Criteria
September 7, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.