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| Name | Class |
|---|---|
| Beijing Sanbo Brain Hospital | OTHER |
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This is a multicenter, prospective, randomized, controlled trial. A total of 165 patients with idiopathic trigeminal neuralgia will be enrolled and randomly divided into three groups at a 1:1:1 ratio. The aim is to compare the efficacy and safety of conventional carbamazepine monotherapy, carbamazepine combined with oral antiviral therapy, and carbamazepine combined with anti-inflammatory therapy in pain relief, quality of life improvement and adverse event profiles.
Idiopathic trigeminal neuralgia is a severe neuropathic pain disorder. Carbamazepine is the first-line conventional treatment, but some patients have insufficient pain relief or intolerable side effects. Viral latent infection and neuroinflammation are considered potential pathogenesis of trigeminal neuralgia. This study intends to explore whether adding oral antiviral agent (acyclovir) or non-steroidal anti-inflammatory drug (celecoxib) can further improve pain control, reduce carbamazepine consumption, improve mood status and quality of life, and ensure clinical safety. All participants will receive 12-week standardized treatment and follow-up at 1 week, 2 weeks, 1 month, 3 months and 6 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Control Group(Carbamazepine Monotherapy) | Other | Intervention:Drug: Carbamazepine Dosage:Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks. |
|
| Arm B:Antiviral Combination Group(Carbamazepine + Acyclovir) | Experimental | Intervention:Drug: Carbamazepine + Acyclovir Dosage:Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks. |
|
| Arm C:Anti-inflammatory Combination Group(Carbamazepine + Celecoxib) | Experimental | Intervention:Drug: Carbamazepine + Celecoxib Dosage:Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention:Drug: Carbamazepine | Drug | ArmA Dosage:Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Visual Analogue Scale (VAS) Pain Score | Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score. | Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (SF-36) Score | 1 week, 2 weeks, 1 month, 3 months | |
| Anxiety and Depression Score (HADS) | 1 week, 2 weeks, 1 month, 3 months | |
| Average Daily Carbamazepine Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianying Li tyli, doctor | Contact | +86-15560392365 | Litypacop@163.com |
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Individual participant data (IPD) will not be shared publicly due to institutional data privacy regulations and patient confidentiality requirements. Data availability is limited to the research team and authorized institutional review personnel only.
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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 |
|---|---|
| D000212 | Acyclovir |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Intervention:Drug: Carbamazepine + Acyclovir | Drug | ArmB Dosage:Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks. |
|
| Intervention:Drug: Carbamazepine + Celecoxib | Drug | Dosage:Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks. |
|
| 1 week, 2 weeks, 1 month, 3 months |
| Adverse Event Incidence | Throughout 12-week treatment and follow-up period |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |