A Hospital-Based Experimental Prospective Study To Compare The Efficacy Of Lycopene And Serratiopeptidase In The Management of Oral Submucous Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The outcome of both the drugs will be compared
研究概览
简要总结
1. The study will include 60 patients diagnosed with OSMF. Based upon theprevious investigations the present sample size was established.
2. Detailed case history will be documented and complete information aboutthe study protocol, necessary follow-up required will be explained and a signedinformed consent will be obtained from each patient.
3. Lycopene 16 mg in two equally divided doses and serratiopeptidase 30 mg in three equallydivided doses will be given for 4 weeks.
4. After establishing the diagnosis for OSMF simple randomization will bedone by registering the patients as they come in the OPD and serial numberstarting from 1 will be assigned to the patients.
5. The study will be double blinded. Blinding of the drugs as well as theinvestigators will be done and third person who is not part of the study willassign the drug to the patients.
6. Blinding of the drug will be done by wrapping a paper around the drugsand by marking them as A and B.
7. Drug A will be assigned to even numbers and drug B will be assigned toodd numbers.
8. When the drug finishes the third person will assign the required drugto the patients.
9. Patients will be evaluated and followed-up in a weekly interval for aperiod of four weeks.
10. The clinical examination will be carried out at every recall visit andthe clinical findings will be recorded with the parameters like mouth opening,burning sensation, tongue protrusion and the palpatory findings.
11. The paper on the drug will beopened after 4 weeks.
Datawill be tabulated and statistical analysis will be done to get the comparativeresults of the two drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •For establishment of oral submucous fibrosis diagnosis, two parame-ters mentioned below were to be satisfied for inclusion in the pre-sent study- (a) Positive history of chewing areca nut or one of its commercial preparations, difficulty in swallowing and chewing and burning sen-sation on eating spicy foods.
- •(b) Restricted mouth opening and changes in the oral mucous mem-brane including the presence of palpable vertical fibrous bands, stiffness and blanching.
排除标准
- •Individuals with other associated oral mucosal lesions or systemic diseases, systemic conditions like pregnancy, lactating mother and those not willing for follow-up.
结局指标
主要结局
The outcome of both the drugs will be compared
时间窗: 4 weeks
次要结局
- 1.The OSMF will be graded clinically according to the classification of Ranganathan et al(2.The mouth opening will be measured with a Vernier Caliper between the incisal tips of both the arches)