Oral Submucous FibrosisPhase 3NCT06758739
Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
A Phase 3 study testing Curcumin (Turmeric) and Intralesional Steroid Injection in people with Oral Submucous Fibrosis, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Curcumin (Turmeric) and Intralesional Steroid Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2025to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.
- Male \& Female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 5400
About this study
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.
Read more
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).
Read the detailed description
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:
Oral submucous fibrosis is chronic, slowly progressive precancerous condition caused by areca nut characterized by restricted mouth opening, burning sensation, stiffness and blanching of mucosa and limitation of tongue Protrusion9. It will be clinically assessed as difficulty in mouth opening, burning sensation, fibrous bands \& blanching of mucosa along with limited tongue movement.
Efficacy:
Efficacy of Curcumin \& intralesional steroids will be assessed in terms of burning sensation VAS score, mouth opening \& Tongue Protrusion
Burning Sensation:
A burning sensation in oral submucous fibrosis is often due to tissue changes, dryness, nutritional deficiencies, or secondary infections affecting the oral mucosa. Patient feels pain or discomfort in mouth especially when eating hot or spicy food Patient will be asked for burning sensation \& based on severity numerical score given by VAS (Visual Analog Scale) (Bohra et al.)9
Mouth Opening:
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 mental scale \& divider (Vernier caliper) between maxillary incisor \& mandibular incisor9.
Tongue Protrusion:
Tongue Protrusion in oral submucous fibrosis refers to the difficulty or inability to fully move the tongue out of the mouth due to stiffness and restricted mobility caused by fibrotic changes in the oral tissues. 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 (Ramesh et al.)11
Material and Methods:
Study Design:
Randomized Central trial (RCT)
Study Setting:
Department of Oral \& Maxillofacial surgery, Services Institute of Medical Sciences Lahore
Duration of Study:
Six months
Sample Size: A sample size will be of 70 patients (35 in each group). Calculated using the expected mean difference of burning sensation VAS score between curcumin group and intralesional steroids inj.
Sampling Technique:
Non-probability purposive sampling technique.
Sample Selection:
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
Data Collection Procedure:
All eligible patients undergoing oral submucous fibrosis treatment will be invited to participate in the study and informed consent will be obtained from all the volunteer participants. Total 70 (35 in each group) will be randomized into two equal size groups i.e. Group A and B by using online computer-generated program which concealed randomization and treatment allocation. A structured Proforma will be used to call demographic and clinical data. Before treatment, baseline burning sensation, mouth opening (interincisal distance) and tongue Protrusion will be noted. In group A, Patient will receive Curcumin Capsule (nutrifactor) 2 per day for 3 months. In group B, Patient will receive intralesional steroid injection 4mg/1cc weekly for 3 months. Participants health care provider, data collector and outcome assessors will be blinded to the treatment allocation. Patient will be assessed for burning sensation, INTERINCISAL DISTANCE \& tongue protrusion monthly. As per operational definitions, efficacy in terms of burning sensation VAS score, greater inter Incisal distance \& tongue Protrusion will be compared between Curcumin and Intralesional steroid groups.
Data Collection Tools:
All Study variables will be assessed by single person at Month 1, Month 2 and Month 3 post clinical trial. Clinical parameters will be assessed through proforma designed in English as well as in Local language.
Data Analysis Procedure:
Statistical Package for Social Sciences (SPSS) version 27 will be used for data entry \& analysis. The quantitative variables such as age, burning sensation VAS score, mouth opening \& tongue Protrusion, will reported using mean ± standard deviation. The quantitative variable such as gender will be reported using percent. The baseline profile between groups will be compared using student t-test. The improvement within the group by the end of 1st, 2nd \& 3rd month will be tabulated \& analyzed. The clinical improvement of a particular regimen (within the same group) before \& after treatment will be analyzed using paired t-test. The improvement observed serially within the same group will be evaluated using repeated measures ANOVA. Comparisons between the two groups will be done using unpaired t-test.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- Curcumin (Turmeric), Intralesional Steroid Injection
- Keywords
- Potentially Malignant Disorder, Oral Submucous Fibrosis, Intralesional Steroids, Curcumin, Anti-Inflammatory, Anti-Fibrotic
- Medical subject headings
- Oral Submucous Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin (Turmeric)Drug
Curcumin Capsule will be given two per day for three months. Patient Recovery progress will be monitored month on month basis for consecutive three month.
Intralesional Steroid InjectionDrug
Intralesional Steroid Injection (1cc), one per week, will be administered in the fibrous bands wherever formed in the oral cavity. Patient recovery progress will be monitored on monthly basis for three months.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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. Receives: Drug: Curcumin (Turmeric) |
| Group B | Experimental | 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. Receives: Drug: Intralesional Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Burning Sensation
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.
Measured: Monthl 1, Month 2, Month 3
Mean of Mouth Opening
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.
Measured: Month 1, Month 2, Month 3
Mean of Tongue Protrusion
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.
Measured: Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Oral Submucous FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hafiza Sara Adrees, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758739
- Sponsor's protocol ID
- U111-1315-4100
- Status last verified
- Mar 2025
- First submitted
- 28 Dec 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kerr AR, Warnakulasuriya S, Mighell AJ, Dietrich T, Nasser M, Rimal J, Jalil A, Bornstein MM, Nagao T, Fortune F, Hazarey VH, Reichart PA, Silverman S, Johnson NW. A systematic review of medical interventions for oral submucous fibrosis and future research opportunities. Oral Dis. 2011 Apr;17 Suppl 1:42-57. doi: 10.1111/j.1601-0825.2011.01791.x.
PubMed 21382138Roques C, Teot L. The use of corticosteroids to treat keloids: a review. Int J Low Extrem Wounds. 2008 Sep;7(3):137-45. doi: 10.1177/1534734608320786. Epub 2008 Jul 8.
PubMed 18611924Ramesh, D.N.S.V., Saba N. lycopene and combination of lycopene with multivitamins in the treatment of oral submucous fibrosis patients - A comparative study. Int. J Curr Res. 2017;9:53177-82.
Piyush P, Mahajan A, Singh K, Ghosh S, Gupta S. Comparison of therapeutic response of lycopene and curcumin in oral submucous fibrosis: A randomized controlled trial. Oral Dis. 2019 Jan;25(1):73-79. doi: 10.1111/odi.12947. Epub 2018 Aug 22.
PubMed 30059188Bohra A, Maheswari TNU, Harsh A, Garg A. Black Turmeric and Aloe Vera in the Management of Oral Submucous Fibrosis: A Prospective Clinical Study. Asian Pac J Cancer Prev. 2021 Dec 1;22(12):3941-3947. doi: 10.31557/APJCP.2021.22.12.3941.
PubMed 34967575Yadav M, Aravinda K, Saxena VS, Srinivas K, Ratnakar P, Gupta J, Sachdev AS, Shivhare P. Comparison of curcumin with intralesional steroid injections in Oral Submucous Fibrosis - A randomized, open-label interventional study. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):169-73. doi: 10.1016/j.jobcr.2014.11.003. Epub 2014 Nov 20.
PubMed 25737939Nagpal M, Sood S. Role of curcumin in systemic and oral health: An overview. J Nat Sci Biol Med. 2013 Jan;4(1):3-7. doi: 10.4103/0976-9668.107253.
PubMed 23633828Zhang SS, Gong ZJ, Li WH, Wang X, Ling TY. Antifibrotic effect of curcumin in TGF-beta 1-induced myofibroblasts from human oral mucosa. Asian Pac J Cancer Prev. 2012;13(1):289-94. doi: 10.7314/apjcp.2012.13.1.289.
PubMed 22502687Aziz SR. Coming to America: betel nut and oral submucous fibrosis. J Am Dent Assoc. 2010 Apr;141(4):423-8. doi: 10.14219/jada.archive.2010.0194.
PubMed 20354091Nigam NK, Aravinda K, Dhillon M, Gupta S, Reddy S, Srinivas Raju M. Prevalence of oral submucous fibrosis among habitual gutkha and areca nut chewers in Moradabad district. J Oral Biol Craniofac Res. 2014 Jan-Apr;4(1):8-13. doi: 10.1016/j.jobcr.2013.10.005. Epub 2013 Nov 20.
PubMed 25737912Rajendran R, Deepthi K, Nooh N, Anil S. alpha4beta1 integrin-dependent cell sorting dictates T-cell recruitment in oral submucous fibrosis. J Oral Maxillofac Pathol. 2011 Sep;15(3):272-7. doi: 10.4103/0973-029X.86678.
PubMed 22144828Pindborg JJ, Sirsat SM. Oral submucous fibrosis. Oral Surg Oral Med Oral Pathol. 1966 Dec;22(6):764-79. doi: 10.1016/0030-4220(66)90367-7. No abstract available.
PubMed 5224185Hazarey VK, Erlewad DM, Mundhe KA, Ughade SN. Oral submucous fibrosis: study of 1000 cases from central India. J Oral Pathol Med. 2007 Jan;36(1):12-7. doi: 10.1111/j.1600-0714.2006.00485.x.
PubMed 17181736
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
- ClinicalTrials.gov ID
- NCT06758739
- Acronym / sponsor ID
- U111-1315-4100
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Potentially Malignant Disorder, Oral Submucous Fibrosis, Intralesional Steroids, Curcumin, Anti-Inflammatory, Anti-Fibrotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
Oral submucous fibrosis is chronic, slowly progressive precancerous condition caused by areca nut characterized by restricted mouth opening, burning sensation, stiffness and blanching of mucosa and limitation of tongue Protrusion9. It will be clinically assessed as difficulty in mouth opening, burning sensation, fibrous bands \& blanching of mucosa along with limited tongue movement.
Efficacy:
Efficacy of Curcumin \& intralesional steroids will be assessed in terms of burning sensation VAS score, mouth opening \& Tongue Protrusion
Burning Sensation:
A burning sensation in oral submucous fibrosis is often due to tissue changes, dryness, nutritional deficiencies, or secondary infections affecting the oral mucosa. Patient feels pain or discomfort in mouth especially when eating hot or spicy food Patient will be asked for burning sensation \& based on severity numerical score given by VAS (Visual Analog Scale) (Bohra et al.)9
Mouth Opening:
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 mental scale \& divider (Vernier caliper) between maxillary incisor \& mandibular incisor9.
Tongue Protrusion:
Tongue Protrusion in oral submucous fibrosis refers to the difficulty or inability to fully move the tongue out of the mouth due to stiffness and restricted mobility caused by fibrotic changes in the oral tissues. 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 (Ramesh et al.)11
Material and Methods:
Study Design:
Randomized Central trial (RCT)
Study Setting:
Department of Oral \& Maxillofacial surgery, Services Institute of Medical Sciences Lahore
Duration of Study:
Six months
Sample Size: A sample size will be of 70 patients (35 in each group). Calculated using the expected mean difference of burning sensation VAS score between curcumin group and intralesional steroids inj.
Sampling Technique:
Non-probability purposive sampling technique.
Sample Selection:
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
Data Collection Procedure:
All eligible patients undergoing oral submucous fibrosis treatment will be invited to participate in the study and informed consent will be obtained from all the volunteer participants. Total 70 (35 in each group) will be randomized into two equal size groups i.e. Group A and B by using online computer-generated program which concealed randomization and treatment allocation. A structured Proforma will be used to call demographic and clinical data. Before treatment, baseline burning sensation, mouth opening (interincisal distance) and tongue Protrusion will be noted. In group A, Patient will receive Curcumin Capsule (nutrifactor) 2 per day for 3 months. In group B, Patient will receive intralesional steroid injection 4mg/1cc weekly for 3 months. Participants health care provider, data collector and outcome assessors will be blinded to the treatment allocation. Patient will be assessed for burning sensation, INTERINCISAL DISTANCE \& tongue protrusion monthly. As per operational definitions, efficacy in terms of burning sensation VAS score, greater inter Incisal distance \& tongue Protrusion will be compared between Curcumin and Intralesional steroid groups.
Data Collection Tools:
All Study variables will be assessed by single person at Month 1, Month 2 and Month 3 post clinical trial. Clinical parameters will be assessed through proforma designed in English as well as in Local language.
Data Analysis Procedure:
Statistical Package for Social Sciences (SPSS) version 27 will be used for data entry \& analysis. The quantitative variables such as age, burning sensation VAS score, mouth opening \& tongue Protrusion, will reported using mean ± standard deviation. The quantitative variable such as gender will be reported using percent. The baseline profile between groups will be compared using student t-test. The improvement within the group by the end of 1st, 2nd \& 3rd month will be tabulated \& analyzed. The clinical improvement of a particular regimen (within the same group) before \& after treatment will be analyzed using paired t-test. The improvement observed serially within the same group will be evaluated using repeated measures ANOVA. Comparisons between the two groups will be done using unpaired t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Curcumin (Turmeric)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. |
| Group B | Experimental | Drug: Intralesional Steroid InjectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.
- Male \& Female
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin (Turmeric)Curcumin Capsule will be given two per day for three months. Patient Recovery progress will be monitored month on month basis for consecutive three month. | Drug | Group A |
| Intralesional Steroid InjectionIntralesional Steroid Injection (1cc), one per week, will be administered in the fibrous bands wherever formed in the oral cavity. Patient recovery progress will be monitored on monthly basis for three months. | Drug | Group B |
Primary outcome
Mean of Burning Sensation
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 21382138Kerr AR, Warnakulasuriya S, Mighell AJ, Dietrich T, Nasser M, Rimal J, Jalil A, Bornstein MM, Nagao T, Fortune F, Hazarey VH, Reichart PA, Silverman S, Johnson NW. A systematic review of medical interventions for oral submucous fibrosis and future research opportunities. Oral Dis. 2011 Apr;17 Suppl 1:42-57. doi: 10.1111/j.1601-0825.2011.01791.x.
- Results publication: PubMed 18611924Roques C, Teot L. The use of corticosteroids to treat keloids: a review. Int J Low Extrem Wounds. 2008 Sep;7(3):137-45. doi: 10.1177/1534734608320786. Epub 2008 Jul 8.
- Results publicationRamesh, D.N.S.V., Saba N. lycopene and combination of lycopene with multivitamins in the treatment of oral submucous fibrosis patients - A comparative study. Int. J Curr Res. 2017;9:53177-82.
- Results publication: PubMed 30059188Piyush P, Mahajan A, Singh K, Ghosh S, Gupta S. Comparison of therapeutic response of lycopene and curcumin in oral submucous fibrosis: A randomized controlled trial. Oral Dis. 2019 Jan;25(1):73-79. doi: 10.1111/odi.12947. Epub 2018 Aug 22.
- Results publication: PubMed 34967575Bohra A, Maheswari TNU, Harsh A, Garg A. Black Turmeric and Aloe Vera in the Management of Oral Submucous Fibrosis: A Prospective Clinical Study. Asian Pac J Cancer Prev. 2021 Dec 1;22(12):3941-3947. doi: 10.31557/APJCP.2021.22.12.3941.
- Results publication: PubMed 25737939Yadav M, Aravinda K, Saxena VS, Srinivas K, Ratnakar P, Gupta J, Sachdev AS, Shivhare P. Comparison of curcumin with intralesional steroid injections in Oral Submucous Fibrosis - A randomized, open-label interventional study. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):169-73. doi: 10.1016/j.jobcr.2014.11.003. Epub 2014 Nov 20.
- Results publication: PubMed 23633828Nagpal M, Sood S. Role of curcumin in systemic and oral health: An overview. J Nat Sci Biol Med. 2013 Jan;4(1):3-7. doi: 10.4103/0976-9668.107253.
- Results publication: PubMed 22502687Zhang SS, Gong ZJ, Li WH, Wang X, Ling TY. Antifibrotic effect of curcumin in TGF-beta 1-induced myofibroblasts from human oral mucosa. Asian Pac J Cancer Prev. 2012;13(1):289-94. doi: 10.7314/apjcp.2012.13.1.289.
- Results publication: PubMed 20354091Aziz SR. Coming to America: betel nut and oral submucous fibrosis. J Am Dent Assoc. 2010 Apr;141(4):423-8. doi: 10.14219/jada.archive.2010.0194.
- Results publication: PubMed 25737912Nigam NK, Aravinda K, Dhillon M, Gupta S, Reddy S, Srinivas Raju M. Prevalence of oral submucous fibrosis among habitual gutkha and areca nut chewers in Moradabad district. J Oral Biol Craniofac Res. 2014 Jan-Apr;4(1):8-13. doi: 10.1016/j.jobcr.2013.10.005. Epub 2013 Nov 20.
- Results publication: PubMed 22144828Rajendran R, Deepthi K, Nooh N, Anil S. alpha4beta1 integrin-dependent cell sorting dictates T-cell recruitment in oral submucous fibrosis. J Oral Maxillofac Pathol. 2011 Sep;15(3):272-7. doi: 10.4103/0973-029X.86678.
- Results publication: PubMed 5224185Pindborg JJ, Sirsat SM. Oral submucous fibrosis. Oral Surg Oral Med Oral Pathol. 1966 Dec;22(6):764-79. doi: 10.1016/0030-4220(66)90367-7. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Oral Submucous Fibrosis
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
Not yet recruiting
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
Oral Submucous Fibrosis
Not yet recruitingObservational study
Evaluation of Functional Dimensions of Macintosh Laryngoscope Blade During Direct Laryngoscopy in Patients With Normal Mouth Opening
Submucous Fibrosis
Not yet recruiting
Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis
Oral Submucous Fibrosis
RecruitingObservational study
EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcumin (Turmeric) and Intralesional Steroid Injection in people with Oral Submucous Fibrosis, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiza Sara Adrees, BDS (+92 307 3002818, saramidrees113@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of Burning Sensation (time frame: Monthl 1, Month 2, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758739, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.