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临床试验/CTRI/2024/11/076144
CTRI/2024/11/076144尚未招募3 期

Trial on effectiveness of omega 3 fatty acid supplements compared to Topical Steroids in Oral Lichen Planus Management

Medona Antony1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
To determine the effectiveness of omega3 fatty acid supplements in the resolution of symptoms of Oral Lichen Planus.

研究概览

简要总结

This study is a Randomized Control Trial to evaluate the Effectiveness of Omega-3 fatty acid supplements in the patients with Oral Lichen Planus.This is a hospital based study, conducting in the Department of Oral Medicine and Radiology, Kannur Dental College. The study duration will be 1 year. Patients in the age group of 18 years and above and clinically diagnosed Oral Lichen Planus  patients according to WHO 2003 criteria will be the inclusion criteria.Exclusion criteria include, the patients having HIV infection and other immuno compromised diseases. Patients on immune suppressant medication for other reasons, cancer chemotherapy, radiotherapy and pregnant and lactating women. All participants will be explained about the study and written informed consent will be obtained. Participants in the study will be randomly allocated using computer software program into intervention and control group , having 21 participants in each group. Group1 will be the control group with 21 participants they will be administered with Topical Corticosteroids and Group 2 will be the intervention group with 21 participants and they will be administered with Topical corticosteroids and 1000mg of Omega-3 fatty acid with 180mg EPA and 120mg DHA. Baseline measurements will be taken using the following outcome measures- VAS score and REU score. At every followup visits on 2nd, 4th, 8th and 12th week the same measures will be used to assess the outcome. Total duration will be 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically diagnosed oral lichen planus patients according to WHO 2003 criteria.
  • 2.Patients in the age group of 18 years and above.

排除标准

  • 1.Patients having HIV infection and other immunocompromised diseases.
  • Patients on immune suppressant medication for other reasons, cancer chemotherapy, radiotherapy.
  • 3.Pregnant and lactating women.

结局指标

主要结局

To determine the effectiveness of omega3 fatty acid supplements in the resolution of symptoms of Oral Lichen Planus.

时间窗: Baseline- 0 day , 1st assessment -2nd week, 2nd assessment- 4th week | 3rd assessment - 8th week | 4th assessmet - 12th week

次要结局

  • To Determine the rapidity of resolution of Oral Lichen Planus using Omega 3 fatty acids supplements.(Baseline- 0 day , 1st assessment -2nd week, 2nd assessment- 4th week)

研究者

发起方
Medona Antony
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Medona Antony

Kannur Dental College

研究点 (1)

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