Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
研究概览
简要总结
All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.
详细描述
This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and for the prevention of post herpetic neuralgia incidence as compared to placebo group. For this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41 patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly follow up for next three months). If it is difficult for the patient to present physically, telephonic follow up will be done to find the pain score in the required time. Also, DLQI (Dermatological life quality index) will be assessed at the first and last visit of the patient.
At the end, pain score will be compared between the two 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of HZ presenting within 72 hours of onset of rash,
- •With pain score 40 or above on 100 mm pain Visual Analogue Scale at the screening visit,
- •Giving written consent for the study.
- •Age between 18-70 years
排除标准
- •HZ presenting after 72 hours of onset
- •Pain score less than 40 at baseline
- •Who took the stable doses of oral analgesics like: NSAIDs, acetaminophen, opioids and antidepressant within six hours of screening visit
- •Using Pregabalin and Gabapentin within last 72 hours
- •Nerve block therapy within the last 48 hours
- •History of hypersensitivity to the drug or its ingredients
- •Use of topical medications within 12 hours
- •Unable to come for follow up because of severe systemic illness
- •Significant hepatic and renal disease,
- •Bed ridden patients or those who are physically unfit for follow up visits.
- •Ethically considered vulnerable members- pregnant/lactating mothers/newborn/children below 12 years /physically or mentally challenged individuals/HIV/ AIDS/IV drug users
研究组 & 干预措施
Pregabalin group
Group 1: Pregabalin tablet 75 mg orally twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Here, the intervention is administration of Pregabalin tablet 75 mg
干预措施: Pregabalin (Drug)
Placebo group
Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
时间窗: Eight months
Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group
次要结局
- Prevention of Post Herpetic Neuralgia(12 months)
研究者
Dr Suchana Marahatta
Associate Professor
B.P. Koirala Institute of Health Sciences