drugset / Trial / NCT06758739
Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2025-04
- Primary completion
- 2025-09
- Completion
- 2025-10
Publications
- Results 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.
- Results Roques 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 Ramesh, 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 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.
- Results Bohra 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 Yadav 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 Nagpal 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 Zhang 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 Aziz 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 Nigam 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 Rajendran 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 Pindborg 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.
- Results Hazarey 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Curcumin | Small molecule | 500 mg | Oral |