Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.
研究概览
简要总结
The purpose of this study is to determine if an herbal over-the-counter cream can decrease skin site reactions in multiple sclerosis patients who currently take either Betaseron, Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis. Injection site reactions have been indicated as one of the major reasons for discontinuing treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple sclerosis.
详细描述
Skin site reactions account for one of the most likely reasons for discontinuation of subcutaneous injections of MS medications. It is imperative that additional methods be determined to decrease the reactions and/or treat the reactions that occur. Individuals continue to use over the counter preparations (e.g. Benadryl or steroid creams) or other treatments recently described (warm compresses) to improve tolerance to the subcutaneous injections and the reactions. Both short (3 to 6 months) and long term skin reactions have been reported by patients. They complain about this at office visits and calls to nurses in clinics or to those who teach injection technique. Recently, this investigator and a nurse colleague found that an herbal cream (Bach's Rescue Remedy Cream) reduced the redness and skin site reactions. A small investigator funded mini-pilot demonstrated a decrease in resolution and in size of skin site reactions and satisfaction of herbal cream versus the placebo cream. This proposed research study builds upon Moore's previous success that documented significant decrease in injection site reactions by adding an air bubble to the injection before injection, which is now described in the injection instructions of Copaxone, Rebif, and Axonex. The specific hypotheses for this study as end points include:
- The herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream.
- The herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream.
- Participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must demonstrate redness of skin site reactions
- •Must demonstrate accurate injection technique prior to initiating the study
排除标准
- •Cannot read the flexible measure and record the results.
- •Are diagnosed with secondary progressive, primary progressive or Devic's MS.
- •Are not taking one of the three subcutaneous injections (Betaseron®, Copaxone® or Rebif®).
- •Are pregnant.
- •Are younger than 18 years of age.
- •Are using combination therapy (e.g., 2 of the immunomodulators, chemotherapy)
- •Have allergies to any topical creams used on skin.
结局指标
主要结局
Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.
时间窗: 7 days from each injection
次要结局
- Participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream(2 weeks)