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Efficacy of Purslane in Treatment of Oral Lichen Planus

Q

Qazvin University Of Medical Sciences

Status and phase

Completed
Phase 2

Conditions

Lichen Planus, Oral

Treatments

Drug: Placebo : one dosage
Drug: Purslane 235mg/day in one dosage

Study type

Interventional

Funder types

Other

Identifiers

NCT00746772
ACTG 023

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

37 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Patients with oral lichen planus
Treatment:
Drug: Purslane 235mg/day in one dosage
2
Placebo Comparator group
Description:
Patients with oral lichen planus
Treatment:
Drug: Placebo : one dosage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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