A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: Curcuminoids; Placebo
Intervention description: Curcuminoids tablets 2000mg three times per day for 12 days
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: curcuminoids; oral lichen planus; c reactive protein; interleukin 6

Summary:

      A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of
      curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with
      OLP presenting to the oral medicine clinic at the University of California, San Francisco,
      will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids
      6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of
      signs, symptoms, periodontal status and blood tests including complete blood count, liver
      enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and
      at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week
      follow-up.

      The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral
      Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in
      symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of
      side-effects, change in serum C-reactive protein and serum interleukin-6 levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the UCSF oral medicine clinic diagnosed with either the
             atrophic or the erosive form of oral lichen planus

          -  Study subjects must have a symptom score between 3 to 8 at the time of entry into the
             study. (Range of scale: zero to ten with zero being no symptoms and ten being the
             worst imaginable symptoms.

          -  Study subjects will have discontinued systemic and/or topical steroids and/or
             curcuminoids for at least 2 weeks before entry into the study.

        Exclusion Criteria:

          -  Pregnancy, lactation or unwillingness to use an effective method of contraception. An
             attempt will be made to ascertain the date of the last menstrual period among eligible
             pre-menopausal women. If pregnancy cannot be ruled out, a pregnancy test will be
             provided to the women before enrollment into the study. - Patients younger than 21
             years of age.

          -  Patients who cannot return for a follow-up visit at two weeks after enrollment.

          -  Patients who have a medical contraindication to discontinuation of systemic steroids
             eg. those on long term corticosteroid therapy. - Patients with a history of
             gastro-esophageal reflux disease, gastric / duodenal ulcers, or gallstones.

          -  Patients with elevated liver enzymes;

          -  Patients on anticoagulants or antiplatelet medications.

          -  Patients undergoing orthodontic treatment.

          -  Patients who don't read, speak or understand English.