Efficacy of Purslane in Treatment of Oral Lichen Planus

NCT00746772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2010-09-08

No results posted yet for this study

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.

Conditions

  • Lichen Planus, Oral

Interventions

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

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 .

Sponsors & Collaborators

  • Qazvin University Of Medical Sciences

    lead OTHER

Principal Investigators

  • farzaneh aghahosseini, professor · Tehran University of Medical Sciences

  • farzaneh aghahosseini, professor · Tehran University of Medical Sciences

  • hamidreza monsef esfehani, PHD · Tehran University of Medical Sciences

  • Katayun Borhanmojabi, DDS-MS · Qazvin University Of Medical Sciences

  • Shahroo Etemad moghadam, DDS-MS · Qazvin University Of Medical Sciences

  • Aida(touba) Karagah, DDS · Qazvin University Of Medical Sciences

  • Eraj mirzaii, physiology · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-05-31
Completion
2008-08-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746772 on ClinicalTrials.gov