Efficacy of Purslane in Treatment of Oral Lichen Planus - Full Text View

Sponsored by:	Qazvin University Of Medical Sciences
Information provided by:	Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00746772

Purpose

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.

Condition	Intervention	Phase
Lichen Planus, Oral	Drug: Purslane 235mg/day in one dosage Drug: Placebo : one dosage	Phase II

MedlinePlus related topics: Antioxidants

Drug Information available for: Starch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Oral Lichen Planus Lesions

Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:

Relief sign &symptom and clinical features [ Time Frame: (every 1 month up to 6months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Relief sign &symptom and clinical features [ Time Frame: (time frame6 months) ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	April 2006
Study Completion Date:	August 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients with oral lichen planus	Drug: Purslane 235mg/day in one dosage 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
2: Placebo Comparator Patients with oral lichen planus	Drug: Placebo : one dosage 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 .

Arms

Assigned Interventions

1: Active Comparator

Patients with oral lichen planus

Drug: Purslane 235mg/day in one dosage

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

2: Placebo Comparator

Patients with oral lichen planus

Drug: Placebo : one dosage

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 .

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746772

Locations

Iran, Islamic Republic of
Qazvin university of medical sciences
qazvin, Iran, Islamic Republic of, 3415759811

Sponsors and Collaborators

Qazvin University Of Medical Sciences

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(tuba) Karagah, student	Qazvin University Of Medical Sciences
Study Director:	Eraj mirzaii, physiology	Tehran University of Medical Sciences

More Information

Responsible Party:	Qazvin university of medical sciences ( Qazvin university of medical sciences (school of dentistry) )
Study ID Numbers:	ACTG 023
Study First Received:	September 2, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00746772
Health Authority:	Iran: Ethics Committee

Keywords provided by Qazvin University Of Medical Sciences:

antioxidant
oral lichen planus
treatment
purslane

Study placed in the following topic categories:

Mouth Diseases
Lichen Planus
Exanthema
Skin Diseases

Oral lichen planus
Stomatognathic Diseases
Skin Diseases, Papulosquamous
Lichen Planus, Oral

Additional relevant MeSH terms:

Lichenoid Eruptions

ClinicalTrials.gov processed this record on January 14, 2009