protocolSection identificationModule nctId: NCT06332612, orgStudyIdInfo id: 8420224AROM, briefTitle: Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial, acronym: MROSF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Ziauddin University, class: OTHER, descriptionModule briefSummary: OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition, conditionsModule conditions: Oral Submucous Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.Groups:* Metformin-treated* Control (untreated)* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: It would be a single-blind, placebo-controlled design, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Metformin Hydrochloride, interventions name: betamethasone dipropionate, interventions name: Pentoxifylline, outcomesModule primaryOutcomes measure: Cell Viability, primaryOutcomes measure: Cytotoxicity, primaryOutcomes measure: Morphological Changes Cell Shape, primaryOutcomes measure: Morphological Change Cell Density, primaryOutcomes measure: Morphological Change Extracellular Matrix (ECM) Structure, primaryOutcomes measure: Cell Migration Assays, primaryOutcomes measure: Cell Invasion Assays, primaryOutcomes measure: Apoptosis Analysis, primaryOutcomes measure: Assess Signaling pathway with optimal metformin concentration, secondaryOutcomes measure: Clinical Oral Mucosal Characteristics, secondaryOutcomes measure: Patient Burning sensation pain, secondaryOutcomes measure: Patient Mouth Opening, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ziauddin University, city: Karachi, state: Sindh, zip: 74700, country: Pakistan, contacts name: Afifa Razi, FCPS OMFS, role: CONTACT, phone: +92 300 2247389, email: afifa.razi@zu.edu.pk, contacts name: Shumaila Usman, PhD, role: CONTACT, phone: +92 336 1882779, email: shumaila.usman@zu.edu.pk, contacts name: Afifa Razi, FCPS, role: PRINCIPAL_INVESTIGATOR, contacts name: Shumaila Usman, PhD, role: SUB_INVESTIGATOR, contacts name: Yamna Khurshid, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False