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临床试验/CTRI/2025/05/087308
CTRI/2025/05/087308尚未招募Phase 3 4

Comparison of efficacy of Pentoxifylline and Lycopene with intralesional Dexamethasone, Hyaluronidase in the treatment of Oral Submucous Fibrosis: A Randomized Controlled Clinical Trial

K J Jalin1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月22日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
mouth opening

研究概览

简要总结

The aim of the study is to Compare the efficacy of oral Pentoxifylline and Lycopene with intralesional Dexamethasone, Hyaluronidase in the treatment of Oral Submucous Fibrosis. Out patients reporting to the Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada who are diagnosed clinically with Oral Submucous Fibrosis and requires treatment will be enrolled in the study. Detailed history of health and habit will be taken and patient will be motivated to quit the habit. The intended procedure will be explained to every patient and an informed consent will be obtained thereafter.  Selected patients will be allocated into group A and B randomly. Group A: Consists of 20 OSMF patients who will be administered Intralesional injection of dexamethasone 1.5ml+ Intralesional injection of hyaluronidase 1500 IU + with 0.5ml lignocaine HCL two times per week for a period of 8 weeks. Group B: Consists of 20 OSMF patients who will be given Tablet Pentoxifylline 400 mg thrice daily combined with oral antioxidant containing Lycopene 10,000 mcg once daily for a period of 8 weeks.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Male and female patients of age 21-60 years clinically diagnosed with OSMF.
  • Patients who are willing to quit the habit of chewing tobacco and areca nut.
  • Patients who will agree to come for regular follow-up visits will be included.

排除标准

  • Patients who are currently under treatment for OSMF.
  • Patients under treatment for chronic systemic diseases such as Diabetes mellitus, Hypertension, Cardiovascular diseases, Bronchial asthma and Peptic ulcers.
  • Pregnant and lactating female patients.
  • OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections.
  • Patients under treatment for other OPMDs.

结局指标

主要结局

mouth opening

时间窗: 18 months

次要结局

  • Burning sensation(18 months)

研究者

发起方
K J Jalin
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

K J Jalin

GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA

研究点 (1)

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