protocolSection identificationModule nctId: NCT06357260, orgStudyIdInfo id: Shifa OMR, briefTitle: Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Postgraduate Institute of Dental Sciences Rohtak, class: OTHER, descriptionModule briefSummary: Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated., conditionsModule conditions: Trigeminal Neuralgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Pregabalin and Carbamazepine, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: VAS score, primaryOutcomes measure: Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory, secondaryOutcomes measure: Patient Global Impression of change(PGI), secondaryOutcomes measure: mean dose of carbamazepine, secondaryOutcomes measure: Liverpool scale, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PGIDS, city: Rohtak, state: Haryana, zip: 124001, country: India, contacts name: DR. Lavina Arya, MDS, role: CONTACT, phone: 09212795285, email: aryalavina@gmail.com, contacts name: Dr. Ambika Gupta, MDS, role: CONTACT, phone: 09315903300, email: drambika79@rediffmail.com, contacts name: Shifa Akhtar, MDS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.89447, lon: 76.58917, hasResults: False