A Randomized, Placebo-Controlled, Double-Blind Trial of a Two Week Course of Curcuminoids in Oral Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Curcumin
Curcumin C3 Complex
干预措施: Curcuminoids (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
时间窗: 2 weeks
Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=\>0-0.25 cm\^2, 2= \>0.25-1 cm\^2, 3=\>=1cm\^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.
次要结局
- Change in Serum C-reactive Protein and Serum Interleukin-6 Levels(2 weeks)
研究者
Nita Chainani Wu
Principal Investigator
University of California, San Francisco