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临床试验/NCT06357260
NCT06357260招募中不适用

Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Visual analogue scale

研究概览

简要总结

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.

详细描述

AIM

Evaluation of Efficacy of Pregabalin as an add on therapy with Carbamazepine in patients with trigeminal neuralgia.

OBJECTIVES

Primary objectives-

  1. To compare the change in pain intensity in both groups.

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
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Test group-1

Experimental

Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need

干预措施: Pregabalin and Carbamazepine (Drug)

Control group

Active Comparator

Carbamazepine with dose of Carbamazepine being titrated as per patients's need

干预措施: Carbamazepine (Drug)

结局指标

主要结局

Visual analogue scale

时间窗: 0-8 weeks

0- no pain 10-worst pain possible .Higher score means worst outcome

Brief pain inventory

时间窗: 0-8 weeks

1-4=mild pain. 07-10 =severe pain. Higher score means worst outcome

次要结局

  • Mean dose of carbamazepine(0-8 weeks)
  • Patient global impression of scale(0-8 weeks)
  • Liverpool scale(0-8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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