Comparative efficacy of topical Basella alba gel and Clobetasol propionate gel for the management of Oral Lichen Planus- a double blinded randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reduction in the intensity of burning sensation and reduction in the size of the lesion
研究概览
简要总结
NULL HYPOTHESIS:
There will be no change in the intensity of burning sensation and size of the lesion on application of Basella albagel in comparison to Clobetasol propionate gel in Oral Lichen planus patients.
ALTERNATIVE HYPOTHESIS:
There will be a change in the intensity of burning sensation and size of the lesion on application of Basella alba gel in comparison to Clobetasol propionate gel in Oral Lichen planus patients.
Clinical evaluation of the efficacy of Basella alba gel and Clobetasol propionate gel:
Clinically diagnosed cases of Oral lichen planus (according to Andreason) with bilateral white striations along with burning sensation will be included in this study. The clinical evaluation of burning sensation will be done using Numeric pain rating scale and the size of the lesion will be measured by a vernier caliper(according to RECIST criteria) by the first investigator. The second investigator will be allocating the patients by randomized concealed chit method (stratified method of allocation will be followed for categorizing Oral lichen planus cases into moderate and severe, using scoring of Malhotra et al,2008) as Group I and Group II ( 32 participants under each group). The application of the gel will be demonstrated to the patients by the second investigator and checked for adverse reaction after a time period of half an hour. The patients will then be advised for topical application ofBasella alba gel and Clobetasol propionate gel respectively with sterile cotton buds thrice a day after breakfast, lunch and dinner. Both the patient and the first investigator will be blinded of the type of intervention. Patients will be recalled after 15, 30, 45, 60 days for reevaluation of burning sensation with Numeric pain rating scale and size of the lesion( RECIST criteria) by the first investigator. The application of gel will be advised until the healing of lesion.
RECIST CRITERIA:
The RECIST system is a simplified tumor measurement by using only the longest uni-dimensional measurement of a lesion, and for multiple lesions, using the sum of the longest diameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 clinically diagnosed with Oral lichen planus (all variants according to Andreason ) irrespective of mucocutaneous involvement.
- •Patients above 18 years of age and of either gender.
- •Patients who are willing to participate in this study.
排除标准
- •Patients with potentially malignant disorders other than Oral lichen planus.
- •Patients with systemic diseases.
- •Pregnant and lactating females.
- •Patients who have already undergone treatment for Oral lichen planus (within the past 3 months).
- •Patients who are allergic to Basella alba gel after oral mucosa patch test.
- •Patients who refuse follow-up.
结局指标
主要结局
Reduction in the intensity of burning sensation and reduction in the size of the lesion
时间窗: 15 days, 30 days, 45 days, 60 days
次要结局
- Whether Basella alba gel can or cannot be used as an alternative treatment modality for the management of Oral Lichen planus and whether it has comparable effects of Clobetasol propionate will be known(15 days, 30 days, 45 days, 60 days)
研究者
Dr Pavithra G
KLE Vishwanath Katti Institute of Dental Sciences