Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis (NCT06758739) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
Pakistan70 participantsStarted 2025-04
Plain-language summary
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:
1. If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid.
2. Does Curcumin treatment results in better mouth opening versus Intralesional steroid.
3. 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.
* Male \& Female
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean of Burning Sensation
Timeframe: Monthl 1, Month 2, Month 3
2
Mean of Mouth Opening
Timeframe: Month 1, Month 2, Month 3
3
Mean of Tongue Protrusion
Timeframe: Month 1, Month 2, Month 3
Trial details
NCT IDNCT06758739
SponsorServices Institute of Medical Sciences, Pakistan