Combination Therapy With Nucleo CMP and Neurorubine Provides Sustained Long-term Pain Control Compared to Carbamazepine in Classical Trigeminal Neuralgia: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Visual Analogue Scale (VAS) Score
研究概览
简要总结
Trigeminal neuralgia is a severe facial pain condition that significantly impacts quality of life. While the standard medication, carbamazepine, provides relief, it is often associated with side effects and rapid pain recurrence upon discontinuation. This randomized clinical trial compares the efficacy and safety of conventional carbamazepine therapy against a novel combination therapy consisting of Nucleo CMP (cytidine monophosphate) and Neurorubine (Vitamin B complex). The study aims to evaluate pain reduction during active treatment and the sustainability of pain control after treatment cessation.
详细描述
Trigeminal neuralgia (TN) is a severe neuropathic pain disorder characterized by paroxysmal electric shock-like pain in the trigeminal nerve distribution. While anticonvulsants, particularly carbamazepine, are the first-line treatment, they often provide incomplete relief, are associated with dose-limiting side effects (sedation, dizziness), and may lead to tolerance over time. This study investigates a novel therapeutic approach targeting nerve regeneration rather than solely symptom suppression.
This randomized, assessor-blinded, parallel-group, active-controlled clinical trial evaluates the efficacy, safety, and long-term sustainability of a combination therapy consisting of Nucleo CMP (cytidine monophosphate) and Neurorubine (Vitamin B complex: B1, B6, B12) compared to conventional carbamazepine therapy.
The study enrolled 38 patients diagnosed with classical trigeminal neuralgia according to International Headache Society criteria. Participants were randomized to one of two arms:
Control Group: Received Carbamazepine initiated at 100mg twice daily, titrated based on response and tolerability up to 400mg twice daily.
Intervention Group: Received a combination protocol. For weeks 1-6, participants took two capsules of Nucleo CMP and two tablets of Neurorubine daily. For weeks 7-9, participants entered a maintenance phase taking one tablet of Neurorubine daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.• Age between 18-80 years
- •Clinical diagnosis of classical trigeminal neuralgia according to International
- •Headache Society (IHS) diagnostic criteria
- •Pain duration of at least 3 months
- •Baseline Visual Analogue Scale (VAS) pain score greater than or equal to 4
- •Ability to provide informed consent and comply with study procedures
- •No contraindications to study medications
排除标准
- •Secondary trigeminal neuralgia due to underlying pathology
- •Atypical facial pain or other orofacial pain conditions
- •Significant cardiovascular, hepatic, or renal disease
- •Pregnancy or lactation
- •Current use of anticonvulsants or other neuropathic pain medications
- •History of allergic reactions to study medications
- •Cognitive impairment preventing reliable pain assessment
- •Concurrent participation in other clinical trials
研究组 & 干预措施
Conventional Carbamazepine Therapy
Participants received conventional carbamazepine tablets administered orally with meals. Treatment was initiated at 100 mg twice daily, with dose titration based on clinical response and tolerability up to a maximum of 400 mg twice daily.
干预措施: Conventional Carbamazepine Therapy (Drug)
Nucleo CMP and Neurorubine Combination
participants received a combination regimen administered orally with meals. During Weeks 1-6, patients took two capsules of Nucleo CMP daily plus two tablets of Neurorubine daily. During Weeks 7-9 (maintenance phase), patients took one tablet of Neurorubine daily.
干预措施: Nucleo CMP and Neurorubine Combination (Drug)
结局指标
主要结局
Change in Pain Intensity Visual Analogue Scale (VAS) Score
时间窗: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
Pain intensity was assessed using a standardized 10-point Visual Analogue Scale (VAS). Patients indicated their pain level on a continuous line anchored by 0 and 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate greater pain intensity. Assessments were recorded at Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation).
次要结局
- Frequency of Pain Attacks(Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation))
研究者
Salah M. Ibrahim
Chief oral surgery department
Kufa University