Oral Submucous FibrosisNCT07891130
Curcumin Plus Topical Steroid Versus Topical Steroid Alone for Oral Submucous Fibrosis
A study testing Curcumin and and triamcinolone acetonide and Triamcinolone Acetonide in people with Oral Submucous Fibrosis, run by Liaquat College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
This study evaluates whether combining oral curcumin (a natural compound derived from turmeric) with a topical steroid is more effective than using a topical steroid alone in treating Oral Submucous Fibrosis (OSMF). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Curcumin and and triamcinolone acetonide and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2025to 5 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-60 years
- Clinical diagnosis of OSMF (Stages I or II based on Haider's classification)
- Burning sensation score ≥ 4 on VAS
- Interincisal mouth opening <35 mm
- Patients with no history of previous OSMF treatment
Who cannot join
- Systemic illness (e.g., diabetes, immunocompromised status)
- Pregnant or lactating women
- Patients currently on any anti-inflammatory, antioxidant, or immunomodulatory drugs
- Known allergy to curcumin or corticosteroids
- TMJ disorders or any mechanical cause of trismus other than OSMF
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat College of Medicine and Dentistry
Karachi, Sindh, 75400
About this study
Official title: Efficacy of Curcumin in Combination With Topical Steroid Versus Topical Steroid Alone in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial
This study evaluates whether combining oral curcumin (a natural compound derived from turmeric) with a topical steroid is more effective than using a topical steroid alone in treating Oral Submucous Fibrosis (OSMF).
OSMF is a chronic mouth condition that can cause burning, tissue stiffness, and difficulty opening the mouth, affecting eating, speaking, and oral hygiene.
Read more
Eligible participants will be randomly assigned to one of two groups:
Group A: Curcumin 500 mg twice daily + 0.1% triamcinolone acetonide ointment three times daily.
Group B: 0.1% triamcinolone acetonide ointment alone, three times daily.
Participants will be followed for six months, with assessments at baseline, 1, 3, and 6 months. Mouth opening and burning sensation will be measured.
Participation is voluntary, and all personal information will remain confidential. Participants may withdraw at any time without affecting their medical care. The study aims to determine whether the combination treatment improves mouth opening and reduces burning sensation more effectively.
Read the detailed description
Oral Submucous Fibrosis (OSMF) is a chronic, progressive, potentially malignant disorder characterized by fibrosis of the oral mucosa and restricted mouth opening. Curcumin, a bioactive polyphenolic compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and potential antifibrotic properties. Topical triamcinolone acetonide is used to manage inflammatory symptoms associated with OSMF. This study will evaluate whether adding oral curcumin to topical triamcinolone acetonide improves clinical outcomes compared with topical triamcinolone acetonide alone.
This randomized, controlled, parallel-group clinical trial will be conducted in the Department of Oral and Maxillofacial Surgery at Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The planned study duration is six months. A total of 60 participants will be allocated in a 1:1 ratio to the two treatment groups using a sealed-envelope randomization method.
Participants assigned to the intervention group will receive oral curcumin 500 mg twice daily in combination with 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Participants assigned to the control group will receive 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Treatment and follow-up will be conducted according to the study protocol.
Clinical assessments will be performed at baseline and at 1, 3, and 6 months. Interincisal mouth opening will be measured in millimeters using a metallic ruler, and burning sensation will be assessed using a 10-point Visual Analog Scale (VAS). A blinded examiner will perform the clinical measurements to reduce observer-related measurement bias.
The primary outcome is the change in interincisal mouth opening from baseline to six months. The secondary outcome is the change in burning sensation VAS score from baseline to six months.
Data will be analyzed using IBM SPSS Statistics, Version 26. Quantitative variables will be summarized using means and standard deviations, where appropriate, and categorical variables using frequencies and percentages. Between-group comparisons will use the independent-samples t-test or Mann-Whitney U test, as appropriate to the distribution of the data. Repeated-measures analysis of variance will be used for within-group comparisons over time, where appropriate, and the chi-square test will be used for categorical variables. Statistical significance will be set at p ≤ 0.05.
The study will compare clinical changes between the two treatment groups to assess whether adjunctive oral curcumin provides additional benefit when combined with topical triamcinolone acetonide for the management of OSMF.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- Curcumin and and triamcinolone acetonide, Triamcinolone Acetonide
- Keywords
- Oral Submucous Fibrosis, Curcumin, Triamcinolone Acetonide, Topical Steroid, Mouth Opening, Burning Sensation
- Medical subject headings
- Oral Submucous Fibrosis, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin and and triamcinolone acetonideOther
Oral curcumin 500 mg administered twice daily for 6 months and topical application of triamcinolone acetonide 3 times a day
Triamcinolone AcetonideDrug
Triamcinolone acetonide 0.1% ointment applied to the affected oral mucosa three times daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin + Topical Steroid | Experimental | Participants receive oral curcumin 500 mg twice daily plus topical triamcinolone acetonide 0.1% three times daily for 6 months. Receives: Other: Curcumin and and triamcinolone acetonide |
| Triamcinolone Acetonide 0.1% | Active comparator | Participants receive topical triamcinolone acetonide 0.1% three times daily for 6 months. Receives: Other: Curcumin and and triamcinolone acetonide; Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
interincisal mouth opening
The change in interincisal mouth opening from baseline to 6 months.
Measured: 1,3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start10 Oct 2025
- Primary completion1 Sep 2026
- Study completion5 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshia Altaf Butt, Liaquat College of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891130
- Sponsor's protocol ID
- Ref.No.IRB/D-000177/25
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
20. Khan AA, Akhter S. Trends of OSMF among adolescents in Lahore. J Coll Physicians Surg Pak. 2022;32(5):603-7.
19. More CB, Rao NR. Proposed clinical classification for OSMF. J Oral Maxillofac Pathol. 2019;23(1):101-6.
16. Ravindra SN, Kumar M, Baroi A. Use of curcumin with antioxidants in OSMF: a clinical study. J Neonatal Surg. 2023;14:2083.
Adhikari S, Rimal J, Maharjan IK, Shrestha A. Efficacy of Curcumin in Combination with Intralesional Dexamethasone with Hyaluronidase in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial. Asian Pac J Cancer Prev. 2022 Sep 1;23(9):3125-3132. doi: 10.31557/APJCP.2022.23.9.3125.
PubMed 36172675Deepak TA, Manjunath M, Thakur H. Efficacy of Curcumin and Topical Steroids in the Treatment for Oral Submucous Fibrosis: A Comparative study. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S542-S548. doi: 10.4103/jpbs.JPBS_687_20. Epub 2021 Jun 5.
PubMed 34447150Guo JC, Xie H, Wu H, Tong TJ. [Efficacy of curcumin in the treatment of oral submucous fibrosis: a Meta-analysis]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2021 Apr 1;39(2):195-202. doi: 10.7518/hxkq.2021.02.011. Chinese.
PubMed 3383467512. Wang Y, Chen X, Li Y. Curcumin suppresses myofibroblast differentiation in OSMF models. Int J Mol Sci. 2021;22(17):9334
Zhang L, Tan J, Liu Y, Luo M. Curcumin relieves arecoline-induced oral submucous fibrosis via inhibiting the LTBP2/NF-kappaB axis. Oral Dis. 2024 May;30(4):2314-2324. doi: 10.1111/odi.14656. Epub 2023 Jun 29.
PubMed 37382472Waghmare M, Pagare S, Bhor K, Srivastava R, Manoj R, Gavand K. Comparing efficacy of curcumin with other treatment modalities in oral submucous fibrosis management - A systematic review and meta-analysis. J Ayurveda Integr Med. 2024 Jul-Aug;15(4):100950. doi: 10.1016/j.jaim.2024.100950. Epub 2024 Jul 9.
PubMed 38986267Chen X, Xie H, Guo J. Drug treatment for oral submucous fibrosis: an update. BMC Oral Health. 2023 Oct 12;23(1):748. doi: 10.1186/s12903-023-03488-9.
PubMed 378284908. Patil S, Maheshwari S, Bagri-Manjrekar K. Curcumin: The Indian solid gold. Oral Oncol. 2017;68:110-8.
She R, Xu P. Mechanism of curcumin in the prevention and treatment of oral submucosal fibrosis and progress in clinical application research. BDJ Open. 2024 Oct 25;10(1):82. doi: 10.1038/s41405-024-00268-7.
PubMed 394555706. More CB, Rao NR, More M, Bhavsar K. Proposed clinical classification for OSMF. J Oral Maxillofac Pathol. 2019;23(1):101-6
5. Khan AA, Akhter S, Rehman S, Mirza T. Trends of OSMF among adolescents in Lahore. J Coll Physicians Surg Pak. 2022;32(5):603-7.
4. Ahmed S, Mehmood A, Iqbal T. Prevalence and risk factors of OSMF in Punjab, Pakistan. Pak Oral Dent J. 2020;40(2):72-6.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Curcumin in Combination With Topical Steroid Versus Topical Steroid Alone in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07891130
- Acronym / sponsor ID
- Ref.No.IRB/D-000177/25
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Oral Submucous Fibrosis, Curcumin, Triamcinolone Acetonide, Topical Steroid, Mouth Opening, Burning Sensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liaquat College of Medicine and DentistryUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 5 Sep 2026 (actual)
- First posted
- 23 Oct 2026 (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.
This study evaluates whether combining oral curcumin (a natural compound derived from turmeric) with a topical steroid is more effective than using a topical steroid alone in treating Oral Submucous Fibrosis (OSMF).
OSMF is a chronic mouth condition that can cause burning, tissue stiffness, and difficulty opening the mouth, affecting eating, speaking, and oral hygiene.
Eligible participants will be randomly assigned to one of two groups:
Group A: Curcumin 500 mg twice daily + 0.1% triamcinolone acetonide ointment three times daily.
Group B: 0.1% triamcinolone acetonide ointment alone, three times daily.
Participants will be followed for six months, with assessments at baseline, 1, 3, and 6 months. Mouth opening and burning sensation will be measured.
Participation is voluntary, and all personal information will remain confidential. Participants may withdraw at any time without affecting their medical care. The study aims to determine whether the combination treatment improves mouth opening and reduces burning sensation more effectively.
Detailed description
Oral Submucous Fibrosis (OSMF) is a chronic, progressive, potentially malignant disorder characterized by fibrosis of the oral mucosa and restricted mouth opening. Curcumin, a bioactive polyphenolic compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and potential antifibrotic properties. Topical triamcinolone acetonide is used to manage inflammatory symptoms associated with OSMF. This study will evaluate whether adding oral curcumin to topical triamcinolone acetonide improves clinical outcomes compared with topical triamcinolone acetonide alone.
This randomized, controlled, parallel-group clinical trial will be conducted in the Department of Oral and Maxillofacial Surgery at Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The planned study duration is six months. A total of 60 participants will be allocated in a 1:1 ratio to the two treatment groups using a sealed-envelope randomization method.
Participants assigned to the intervention group will receive oral curcumin 500 mg twice daily in combination with 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Participants assigned to the control group will receive 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Treatment and follow-up will be conducted according to the study protocol.
Clinical assessments will be performed at baseline and at 1, 3, and 6 months. Interincisal mouth opening will be measured in millimeters using a metallic ruler, and burning sensation will be assessed using a 10-point Visual Analog Scale (VAS). A blinded examiner will perform the clinical measurements to reduce observer-related measurement bias.
The primary outcome is the change in interincisal mouth opening from baseline to six months. The secondary outcome is the change in burning sensation VAS score from baseline to six months.
Data will be analyzed using IBM SPSS Statistics, Version 26. Quantitative variables will be summarized using means and standard deviations, where appropriate, and categorical variables using frequencies and percentages. Between-group comparisons will use the independent-samples t-test or Mann-Whitney U test, as appropriate to the distribution of the data. Repeated-measures analysis of variance will be used for within-group comparisons over time, where appropriate, and the chi-square test will be used for categorical variables. Statistical significance will be set at p ≤ 0.05.
The study will compare clinical changes between the two treatment groups to assess whether adjunctive oral curcumin provides additional benefit when combined with topical triamcinolone acetonide for the management of OSMF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin + Topical Steroid | Experimental | Other: Curcumin and and triamcinolone acetonideParticipants receive oral curcumin 500 mg twice daily plus topical triamcinolone acetonide 0.1% three times daily for 6 months. |
| Triamcinolone Acetonide 0.1% | Active comparator | Other: Curcumin and and triamcinolone acetonide, Drug: Triamcinolone AcetonideParticipants receive topical triamcinolone acetonide 0.1% three times daily for 6 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20-60 years
Key exclusion criteria (5 listed)
- Systemic illness (e.g., diabetes, immunocompromised status)
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 and and triamcinolone acetonideOral curcumin 500 mg administered twice daily for 6 months and topical application of triamcinolone acetonide 3 times a day | Other | Curcumin + Topical Steroid, Triamcinolone Acetonide 0.1% |
| Triamcinolone AcetonideTriamcinolone acetonide 0.1% ointment applied to the affected oral mucosa three times daily for 6 months. | Drug | Triamcinolone Acetonide 0.1% |
Primary outcome
interincisal mouth opening
Time frame: 1,3, and 6 months
The change in interincisal mouth opening from baseline to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background20. Khan AA, Akhter S. Trends of OSMF among adolescents in Lahore. J Coll Physicians Surg Pak. 2022;32(5):603-7.
- Background19. More CB, Rao NR. Proposed clinical classification for OSMF. J Oral Maxillofac Pathol. 2019;23(1):101-6.
- Background16. Ravindra SN, Kumar M, Baroi A. Use of curcumin with antioxidants in OSMF: a clinical study. J Neonatal Surg. 2023;14:2083.
- Background: PubMed 36172675Adhikari S, Rimal J, Maharjan IK, Shrestha A. Efficacy of Curcumin in Combination with Intralesional Dexamethasone with Hyaluronidase in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial. Asian Pac J Cancer Prev. 2022 Sep 1;23(9):3125-3132. doi: 10.31557/APJCP.2022.23.9.3125.
- Background: PubMed 34447150Deepak TA, Manjunath M, Thakur H. Efficacy of Curcumin and Topical Steroids in the Treatment for Oral Submucous Fibrosis: A Comparative study. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S542-S548. doi: 10.4103/jpbs.JPBS_687_20. Epub 2021 Jun 5.
- Background: PubMed 33834675Guo JC, Xie H, Wu H, Tong TJ. [Efficacy of curcumin in the treatment of oral submucous fibrosis: a Meta-analysis]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2021 Apr 1;39(2):195-202. doi: 10.7518/hxkq.2021.02.011. Chinese.
- Background12. Wang Y, Chen X, Li Y. Curcumin suppresses myofibroblast differentiation in OSMF models. Int J Mol Sci. 2021;22(17):9334
- Background: PubMed 37382472Zhang L, Tan J, Liu Y, Luo M. Curcumin relieves arecoline-induced oral submucous fibrosis via inhibiting the LTBP2/NF-kappaB axis. Oral Dis. 2024 May;30(4):2314-2324. doi: 10.1111/odi.14656. Epub 2023 Jun 29.
- Background: PubMed 38986267Waghmare M, Pagare S, Bhor K, Srivastava R, Manoj R, Gavand K. Comparing efficacy of curcumin with other treatment modalities in oral submucous fibrosis management - A systematic review and meta-analysis. J Ayurveda Integr Med. 2024 Jul-Aug;15(4):100950. doi: 10.1016/j.jaim.2024.100950. Epub 2024 Jul 9.
- Background: PubMed 37828490Chen X, Xie H, Guo J. Drug treatment for oral submucous fibrosis: an update. BMC Oral Health. 2023 Oct 12;23(1):748. doi: 10.1186/s12903-023-03488-9.
- Background8. Patil S, Maheshwari S, Bagri-Manjrekar K. Curcumin: The Indian solid gold. Oral Oncol. 2017;68:110-8.
- Background: PubMed 39455570She R, Xu P. Mechanism of curcumin in the prevention and treatment of oral submucosal fibrosis and progress in clinical application research. BDJ Open. 2024 Oct 25;10(1):82. doi: 10.1038/s41405-024-00268-7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and and triamcinolone acetonide and Triamcinolone Acetonide in people with Oral Submucous Fibrosis, run by Liaquat College of Medicine and Dentistry 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 Oct 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interincisal mouth opening (time frame: 1,3, and 6 months). 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 NCT07891130, which also lists 18 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 23 Oct 2026.