Efficacy of Purslane in Treatment of Oral Lichen Planus

NCT00746772 | Completed Phase 2

• 1 other identifier: ACTG 023
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Planus, Oral

Keywords

antioxidant; oral lichen planus; treatment; purslane

Outcome Measures

Primary Outcomes (1)

• Relief sign &symptom and clinical features

  (every 1 month up to 6months)

Secondary Outcomes (1)

• Relief sign &symptom and clinical features

  (time frame6 months)

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with oral lichen planus

Drug: Purslane 235mg/day in one dosage

2

PLACEBO COMPARATOR

Patients with oral lichen planus

Drug: Placebo : one dosage

Interventions

Purslane 235mg/day in one dosage 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

Also known as: Portulaca oleracea.

1

Placebo : one dosage 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 .

Also known as: starch

2

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin university of medical sciences

Qazvin, Qazvin Province, 3415759811, Iran

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Starch

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• farzaneh aghahosseini, professor

  Tehran University of Medical Sciences

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Aida(touba) Karagah, DDS

  Qazvin University Of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Eraj mirzaii, physiology

  Tehran University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: April 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 8, 2010

Record last verified: 2010-09

Locations

IR (1)