Comparison of Topical Purslane & topical 0.1% triamcinolone acetonide in the management of Oral Lichen Planus - A double blinded clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Alllieviatiom of burning sensation
研究概览
简要总结
To assess the efficacy of topical purslane in two concentrations (5% &10%) in treating symptomatic oral lichen planus.
To assess the efficacy of topical 0.1% triamcinolone acetonide gel in symptomatic oral lichen planus.
To compare the level of clinical improvement on oral lichen planus patients using purslane and 0.1% triamcinolone acetonide gel.
No statistically significant difference between the compared groups pertaining to the study variables (burning sensation, pain, lesion score, symptomatic response of burning sensation, symptomatic response of pain, clinical response) at all the five time periods (baseline, 2 weeks, 1 month, 2 months and 3 months). Intragroup comparison revealed that there was a statistically significant difference between the five time periods (baseline, 2 weeks, 1 month, 2 months and 3 months) for the study variables (burning sensation, pain, lesion score) for all the three groups (p=0.001). No burning sensation, pain as well as lesion was observed for all the three groups at the end of three months.
This study implies Topical Purslane gel can be used as an safer alternative treatment modality for alleviating the symptoms of Oral Lichen planus with lesser side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to participate in the study.
- •Patients with symptomatic (burning sensation or pain) reticular type oral lichen planus and who had not under gone any previous treatment for the same in the last six months.
- •Clinically and histopathologically confirmed Oral lichen Planus.
- •Patients with other systemic diseases ( Diaebtes & hypertension) & those not under any long term glucocorticosteroid therapy.
排除标准
- •Histopathologically proven lichenoid reaction.
- •Patients with other white lesions like leukoplakia, systemic lupus erythematosus(SLE) along with oral lichen planus.
- •Patients with other systemic diseases & those on long term glucocorticosteroid therapy.
- •Patients having extra oral manifestations of oral lichen planus during the duration of treatment.
- •Pregnancy, lactation.
- •History of allergic reactions to herbal preparations.
结局指标
主要结局
Alllieviatiom of burning sensation
时间窗: Baseline, 2nd week,1st,2nd & 3rd month
次要结局
- Relief of symptoms(3 months)