Subcutaneous Calcitonin in Acute Herpes Zoster
The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
研究概览
详细说明
Herpes zoster is associated with inflammation of the dorsal root ganglion and peripheral nerves, and this inflammation is considered to be an important causative factor for postherpetic neuralgia.
Interventions aimed at reducing this inflammation should therefore be effective in decreasing the likelihood of developing postherpetic neuralgia. Epidural administration of corticosteroids and local anesthetics has been shown to be effective, but is associated with the risk of arachnoiditis. Subcutaneous injection in an outpatient setting may be effective in preventing postherpetic neuralgia and is also considerably safer. Calcitonin has previously been shown to be effective in the management of acute pain following amputation. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke. Also, a previous case report revealed that IV calcitonin provided immediate and sustained improvement in post herpetic neuralgia for over two months, without adverse effects from the calcitonin therapy.
However, no previous trials evaluated the effect of subcutaneous calcitonin as a preventive measure against the development of postherpetic neuralgia. We will conduct this study as we hypothesize that calcitonin therapy in patients with acute herpes zoster may be associated with better acute pain control and therefore may decrease the incidence of postherpetic neuralgia.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Amira M Elkeblawy, MD
- 电话号码:002 01148529429
- 邮箱:marmoramero999@gmail.com
学习地点
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Gharbia Governorate
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Tanta、Gharbia Governorate、埃及、31527
- 招聘中
- Tanta University Hospitals
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接触:
- Amira M Elkeblawy, MD
- 电话号码:002 01148529429
- 邮箱:marmoramero999@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- patients aged ≥ 50 years, with acute herpes zoster infection (rash duration < 7 days) and moderate to severe pain.
Exclusion Criteria:
- Coagulation abnormalities
- Pre-existing other pain syndrome or psychological disorders.
- Severe hepatic, cardiovascular, or renal disorders.
- Allergy to calcitonin.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Calcitonin group
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks.
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patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks
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安慰剂比较:Control group
patients will receive subcutaneous saline (1 ml) daily for three weeks.
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patients will receive subcutaneous saline (1 ml) daily for three weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of postherpetic neuralgia at 3 months after rash onset.
大体时间:3 months after onset of acute herpes zoster rash.
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A numeric rating scale (NRS) that ranged from 0 for "no pain" to 10 for "worst ever pain will be used to assess the degree of pain.
Pain score more than (3) at 3 months after onset of acute herpes zoster rash will be considered positive for the occurrence of postherpetic neuralgia.
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3 months after onset of acute herpes zoster rash.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of postherpetic neuralgia.
大体时间:6 months after onset of acute herpes zoster rash.
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Pain score more than 3.
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6 months after onset of acute herpes zoster rash.
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Severity of acute herpes zoster pain.
大体时间:Up to 1 month after onset of acute herpes zoster rash.
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A numeric rating scale (NRS) that ranged from 0 for "no pain" to 10 for "worst ever pain will be used to assess the degree of pain.
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Up to 1 month after onset of acute herpes zoster rash.
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Number of medications used to treat pain.
大体时间:up to 6 months after onset of acute herpes zoster rash.
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Analgesics, anti-neuropathic pain medications and opioids will be recorded.
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up to 6 months after onset of acute herpes zoster rash.
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Side effects
大体时间:Up to 1 month after onset of acute herpes zoster rash.
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Vomiting
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Up to 1 month after onset of acute herpes zoster rash.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 36265PR14/4/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
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研究美国 FDA 监管的药品
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