Efficacy of Purslane in Treatment of Oral Lichen Planus

NCT ID: NCT00746772

Last Updated: 2010-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-08-31

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.

Conditions

Lichen Planus, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Patients with oral lichen planus

Group Type: ACTIVE_COMPARATOR

Purslane 235mg/day in one dosage

Intervention Type: DRUG

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

Patients with oral lichen planus

Group Type: PLACEBO_COMPARATOR

Placebo : one dosage

Intervention Type: DRUG

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 .

Interventions

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

Intervention Type: 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 .

Intervention Type: DRUG

Other Intervention Names

Portulaca oleracea.; starch

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qazvin University Of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Qazvin university of medical sciences

Principal Investigators

farzaneh aghahosseini, professor

Role: STUDY_CHAIR

Tehran University of Medical Sciences

farzaneh aghahosseini, professor

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

hamidreza monsef esfehani, PHD

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Katayun Borhanmojabi, DDS-MS

Role: STUDY_DIRECTOR

Qazvin University Of Medical Sciences

Shahroo Etemad moghadam, DDS-MS

Role: STUDY_DIRECTOR

Qazvin University Of Medical Sciences

Aida(touba) Karagah, DDS

Role: PRINCIPAL_INVESTIGATOR

Qazvin University Of Medical Sciences

Eraj mirzaii, physiology

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Locations

Qazvin university of medical sciences

Qazvin, Qazvin Province, Iran

Countries

Iran

Other Identifiers

ACTG 023

Identifier Type: -

Identifier Source: org_study_id