Evaluation of the efficacy of oral Carbamazepine therapy versus oral Carbamazepine Boswellia Curcumin combination therapy and oral Boswellia curcumin monotherapy in patients with Trigeminal Neuralgia A Randomized Controlled Trail
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a randomized controlled clinical trial conducted at the Department of Oral Medicine and Radiology, Tamil Nadu Government Dental College and Hospital, Chennai, to evaluate and compare the efficacy of three treatment modalities in patients with newly diagnosed trigeminal neuralgia. A total of 63 patients will be randomly allocated into three groups: Group A receiving oral carbamazepine (200 mg twice daily), Group B receiving a combination of oral carbamazepine (200 mg) and Boswellia–Curcumin (500 mg) twice daily, and Group C receiving oral Boswellia–Curcumin monotherapy (500 mg twice daily), all for a duration of 15 week.
Diagnosis will be made based on International Headache Society criteria, supported by clinical examination and local anesthetic nerve block testing. Patients will be followed up at 2, 6, and 15 weeks. Treatment efficacy will be assessed using the Modified Brief Pain Inventory (BPI), evaluating pain intensity and frequency of paroxysms. Statistical analysis will be performed using SPSS version 26. The study aims to determine whether Boswellia–Curcumin, alone or in combination with carbamazepine, offers comparable or improved pain control with potentially fewer adverse effects compared to conventional carbamazepine therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who were diagnosed with Trigeminal Neuralgia for the first time Patient willing to participate in the study and has the ability to complete the study.
排除标准
- •Patients who were previously diagnosed with Trigeminal Neuralgia Not willing to participate in the study Lactating or pregnant women Allergic, immunocompromised or systemic illness patients Asymptomatic patients.
研究者
Dr Khajal K
Tamilnadu Government Dental College and Hospital
