A Randomised Parallel Clinical Trial To Compare The Efficacy Of Topical Application Of 97% Aloe Vera Gel Along With 94.7% Aloe Vera Juice Versus 0.05% Clobetasol Propionate Topical Application In The Treatment Of Oral Lichen Planus

Dr Aniket Uday Vaidya1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2016年9月9日最近更新: 2020年8月18日

研究概览

简要总结

This study is a randomized, parallel group, clinical trial comparing the efficacy topical application of 97% Aloe vera gel and 94.7% Aloe vera juice versus 0.05% Clobetasol Propionate Ointment topical application for 2 months in 60 patients with Oral lichen Planus. This study will include the patients attending the Oral Medicine and Radiology Dept. Out Patient Dept., Goa Dental College and Hospital, Bambolim, Goa. All the patients will be followed up on monthly basis for a period of 6 months. The primary outcome measures will be difference in the size of the lesion, difference in the VAS score, number of sites involved, lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative, extra-oral site involvement, if any. The secondary outcomes will be changes histological characteristics before and after treatment, recurrence rate and safety of the drugs / adverse reactions.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Patients with clinically diagnosed and histologically confirmed Oral Lichen Planus lesions will be included.
•Age group above 18 years.
•Patient willing to participate in the study and sign the informed consent.
•Patients given medical clearance by General Medicine Dept., Goa Medical College for being included in the trial in spite of of the medical conditions like hypertension, diabetes mellitus and hyperthyroidism etc
•If patient is under any other systemic medications or topical treatment for oral lichen planus then in such cases the patients will be included in this study three months after cessation of the current systemic steroidal treatment or one month after cessation of non-steroidal systemic treatment or steroidal / non-steroidal topical treatment if the lesions have still persisted.

排除标准

•Patients who were clinically diagnosed as OLP but thereafter not confirmed histologically or histologically diagnosed as lichenoid reaction.
•History of allergy to 0.05% Clobetasol Propionate Ointment or 97 % pure Aloe Vera gel and 94.7% pure Aloe Vera juice.
•Medically compromised patients who could not be put on topical steroids or Aloe Vera as advised by the General Medicine Dept., Goa Medical College, Bambolim-Goa.
•Pregnant or Lactating females.