Efficacy of Purslane in Treatment of Oral Lichen Planus

This study has been completed.
Sponsor:
Information provided by:
Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00746772
First received: September 2, 2008
Last updated: September 7, 2010
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Oral Lichen Planus Lesions

Resource links provided by NLM:


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
Active Comparator: 1
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
Other Name: Portulaca oleracea.
Placebo Comparator: 2
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 .
Other Name: starch

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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(touba) Karagah, DDS Qazvin University Of Medical Sciences
Study Director: Eraj mirzaii, physiology Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Qazvin university of medical sciences (school of dentistry), Qazvin university of medical sciences
ClinicalTrials.gov Identifier: NCT00746772     History of Changes
Other Study ID Numbers: ACTG 023
Study First Received: September 2, 2008
Last Updated: September 7, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Qazvin University Of Medical Sciences:
antioxidant
oral lichen planus
treatment
purslane

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014