Efficacy of Purslane in Treatment of Oral Lichen Planus
Primary Purpose
Lichen Planus, Oral
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Purslane 235mg/day in one dosage
Placebo : one dosage
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Planus, Oral focused on measuring antioxidant, oral lichen planus, treatment, purslane
Eligibility Criteria
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
Sites / Locations
- Qazvin university of medical sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Patients with oral lichen planus
Patients with oral lichen planus
Outcomes
Primary Outcome Measures
Relief sign &symptom and clinical features
Secondary Outcome Measures
Relief sign &symptom and clinical features
Full Information
NCT ID
NCT00746772
First Posted
September 2, 2008
Last Updated
September 7, 2010
Sponsor
Qazvin University Of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00746772
Brief Title
Efficacy of Purslane in Treatment of Oral Lichen Planus
Official Title
Treatment of Oral Lichen Planus Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Qazvin University Of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral
Keywords
antioxidant, oral lichen planus, treatment, purslane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients with oral lichen planus
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients with oral lichen planus
Intervention Type
Drug
Intervention Name(s)
Purslane 235mg/day in one dosage
Other Intervention Name(s)
Portulaca oleracea.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo : one dosage
Other Intervention Name(s)
starch
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Relief sign &symptom and clinical features
Time Frame
(every 1 month up to 6months)
Secondary Outcome Measure Information:
Title
Relief sign &symptom and clinical features
Time Frame
(time frame6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farzaneh aghahosseini, professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
farzaneh aghahosseini, professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
hamidreza monsef esfehani, PHD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katayun Borhanmojabi, DDS-MS
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shahroo Etemad moghadam, DDS-MS
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aida(touba) Karagah, DDS
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eraj mirzaii, physiology
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Qazvin university of medical sciences
City
Qazvin
ZIP/Postal Code
3415759811
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Purslane in Treatment of Oral Lichen Planus
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