Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean of Burning Sensation
研究概览
简要总结
The goal of this clinical trial is to learn if Curcumin is better than Intralesional Steroid Injection for the treatment of oral submucous fibrosis. The main question it aims to answers are:
- If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid.
- Does Curcumin treatment results in better mouth opening versus Intralesional steroid.
- Can Curcumin helps to improve tongue protrusion as compared to Intralesional steroids.
Participants will be:
- Assessed for one month, two month and three month.
- Burning Sensation will be assessed with visual analogue scale (VAS).
- Mouth Opening will be measured in mm with ruler.
- Tongue Protrusion will be assessed with the visual analogue scale (VAS).
详细描述
Objective:
To compare the efficacy of Curcumin versus Intralesional steroids in term of burning sensation, mouth opening and tongue Protrusion
Hypothesis:
Curcumin is more effective in terms of burning sensation, mouth opening (interincisal distance) and tongue Protrusion as compared to intralesional steroids.
Operational Definitions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.
- •Male & Female
排除标准
- •Patient unable to quit the habit of gutkha, tobacco & betel nut chewing
- •Patient With uncontrolled diabetes
- •Patient with chronic kidney disease
- •Pregnant female
- •Patient with untreated malignancy/taking immunosuppressant drugs
- •Patient with H/O ORAL SUBMUCOUS FIBROSIS in last months
研究组 & 干预措施
Group A
The Group A will undergo curcumin treatment for oral submucous Fibrosis. In Group A curcumin capsule (500 mg) will be given two per day. Patient will receive 1000 mg curcumin per day and will be assessed month on month basis for three months.
干预措施: Curcumin (Turmeric) (Drug)
Group B
The Group B will undergo Intralesional Steroids treatment in oral submucous fibrosis. In Group B Intralesional Steroid Injection will be administered weekly and assessed on monthly basis for three months.
干预措施: Intralesional Steroid Injection (Drug)
结局指标
主要结局
Mean of Burning Sensation
时间窗: Monthl 1, Month 2, Month 3
A burning sensation in oral submucous fibrosis is often due to tissue changes, dryness, nutritional deficiencies, or secondary infections affecting the oral mucosa. Patient will be asked for burning sensation \& based on severity numerical score given by VAS (Visual Analog Scale) 0-100.
Mean of Mouth Opening
时间窗: Month 1, Month 2, Month 3
Mouth opening is progressively restricted due to fibroses and stiffness of oral tissue. It will be measured in mm. Patient will be asked to open mouth as wide as he/she can \& with the help of metal scale \& divider (Vernier caliper) between maxillary incisor \& mandibular incisor.
Mean of Tongue Protrusion
时间窗: Month 1, Month 2, Month 3
Tongue Protrusion in oral submucous fibrosis refers to the difficulty or inability to fully move the tongue out of the mouth. It will be assessed from normal mesio-incisal angel of maxillary central incisor to the tip of tongue when maximally extended with wide mouth open by Visual Analogue Scale (VAS) 0-100.
次要结局
未报告次要终点
研究者
Hafiza Sara Adrees
Post Graduate Resident OMFS
Services Institute of Medical Sciences, Pakistan