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In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine
In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbamazepine group | Active Comparator | In this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management |
|
| Oxcarbazepine group | Active Comparator | In this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbamazepine | Drug | Carbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief for TGN | Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document. | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Side effects of each drug will be compared including hepatotoxicity through liver functional tests, and other effects including nausea tolerability, dizziness etc. Annexure will be provided to each group participants ( same as mentioned in primary outcome section) ,which includes side effects column specifically Liver Functional Test results including both baselines values ( during the start of treatment ) and final results( at the end of treatment) and comparison will be made between the two drugs regarding side effects specifically hepatotoxicity. |
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Inclusion Criteria:
Exclusion Criteria [Expanded]:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.SUFYAN AHMED, FCPS | KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbassi Shaheed hospital Facio-Maxillary Department | Karachi | Sindh | 75500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. International Headache Society. The International Classification of Headache Disorders (ICHD-3) - online edition, updated 2023. Available at: https://ichd-3.org |
| Label | URL |
|---|---|
| Related Info | View source |
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Primary and secondary outcomes
As soon as the article will get published , probably from next year (2027)
PUBLIC
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| oxcarbazepine | Drug | Oxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity |
|
| Two months |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |