To evaluate efficacy and safety of eperisone hydrochloride vs chlorzoxazone in patients with myofascial pain dysfunction syndrome :A randomized controlled double Blinded open labelled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 1.Benefit in improvement of pain intensity
研究概览
简要总结
This is Double Blinded Randomized Controlled trial Open Labelled, comparing the efficacy of eperisone hydrochloride (50mg) and Chlorzoxazone (250mg) along with paracetamol twice daily for 7 days in 28 patients with myofascial pain dysfunction syndrome in India. The primary outcomes are expected to benefit in improvement in pain intensity ,duration of reduction. They will be assessed at baseline, day 3 ,day 5 and day 7.The secondary outcome will be evaluated as adverse effects at baseline and on 7th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients attending outpatient department both male and female between 20 to 55 yrs.
- •2.Presence of unilateral pain, muscle tenderness, Clicking or popping noise in the TMJ, Limitation of jaw movement.
- •3.No radiographic evidence of bony pathology.
- •4.No tenderness in TMJ area on palpation via the external auditory meatus.
- •5.Willing to take medications as directed and come for follow up were included.
排除标准
- •1.Bilaterally Edentulous arches 2.Pregnant or lactating women 3.Patient with known H/O hypersensitivity to any of the trial drugs 4.Medical disease like suffering from hematologic /endocrine/impaired liver function/kidney disorder.
- •5.Unwilling to be a part of study.
结局指标
主要结局
1.Benefit in improvement of pain intensity
时间窗: At baseline,3rd day,5th day,7th day.
2.Benefit in duration of pain reduction
时间窗: At baseline,3rd day,5th day,7th day.
3.Improvemet in mouth opening.
时间窗: At baseline,3rd day,5th day,7th day.
次要结局
- Incidence of any adverse Effects(At baseline,7 days)
研究者
Dr Pranali Mohan Mane
D Y Patil School Of Dentistry , Nerul ,Navi Mumbai ,