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临床试验/CTRI/2024/06/069548
CTRI/2024/06/069548尚未招募Unknown

Comparative evaluation of efficacy of topical application of Spirulina gel 1 percent and triamcinolone acetonide 0.1 percent in the management of Oral Lichen Planus- A randomized controlled trial

Dr Nitika Aggarwal1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Burning sensation

研究概览

简要总结

Oral lichen planus is chronic inflammatory muco-cutaneous immune mediated disorder that affects skin and oral mucous membrane. It most commonly involves middle aged patients with mean age between 30-60 years. Extensive research and numerous trials have been conducted to determine the most efficacious and safe treatments for OLP. The treatment of oral lichen planus has always posed a challenge to the dental surgeon. Steroids form the mainstay treatment modality for oral lichen planus. Amongst steroids, triamcinolone acetonide forms the drug of choice owing to its intermediately acting nature and ease of absorption from the oral mucous membrane. Necessity is the mother of invention. And hence to overcome the adverse effects newer therapeutic agents have time and again been tried and tested. One such agent is the commercially available superfood- Spirulina. Spirulina contains functional compounds, such as phenolics, phycocyanins, and polysaccharides, with antioxidant, antiinflammatory, and immunostimulating effects. This study aims to evaluate the efficacy of spirulina in the treatment of oral lichen planus and compare it with corticosteroids.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All clinically Diagnosed cases with atrophic, erosive, reticular or any other form of oral lichen Planus.
  • Patients above 21 years of age.
  • Patients with no contraindications or documented allergies to the medications which are being used for study.
  • Patients willing to participate in the study.

排除标准

  • Previously treated patients of oral lichen planus in last 3 months or those who have left treatment in-between, or undergoing any other treatment modality.
  • Patients with co-existing systemic illness like diabetes mellitus, hypertension.
  • Pregnant and lactating mother.

结局指标

主要结局

Burning sensation

时间窗: weekly for 4 weeks, after that 15 days for 1 month

(Visual analog

时间窗: weekly for 4 weeks, after that 15 days for 1 month

scale),

时间窗: weekly for 4 weeks, after that 15 days for 1 month

Size of the lesion

时间窗: weekly for 4 weeks, after that 15 days for 1 month

(using vernier

时间窗: weekly for 4 weeks, after that 15 days for 1 month

caliper),

时间窗: weekly for 4 weeks, after that 15 days for 1 month

Clinical assessment

时间窗: weekly for 4 weeks, after that 15 days for 1 month

(Thongprasom

时间窗: weekly for 4 weeks, after that 15 days for 1 month

score)

时间窗: weekly for 4 weeks, after that 15 days for 1 month

次要结局

  • To record the adverse reactions, if any, with both the drugs in either of the two groups,(To record the recurrence of the lesion in any of the two groups)

研究者

发起方
Dr Nitika Aggarwal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nitika Aggarwal

Government dental college and hospital, Mumbai

研究点 (1)

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