Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple S
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Bach's Rescue Remedy Cream
Placebo
- Placebo Cream
What it measured
Main measures
Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.
7 days from each injection
Other measures (1)
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
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Participants must demonstrate redness of skin site reactions * Must demonstrate accurate injection technique prior to initiating the study
Exclusion criteria
* 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.Background
Moore LA, Kaufman MD, Algozzine R, Irish N, Martin M, Posey CR. Adherence to therapy: using an evidence-based protocol. Rehabil Nurs. 2007 Nov-Dec;32(6):227-32. doi: 10.1002/j.2048-7940.2007.tb00179.x.Background
Jolly H, Simpson K, Bishop B, Hunter H, Newell C, Denney D, Oleen-Burkey M. Impact of warm compresses on local injection-site reactions with self-administered glatiramer acetate. J Neurosci Nurs. 2008 Aug;40(4):232-9. doi: 10.1097/01376517-200808000-00007.Background
Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.
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History
Started
Jun 2009
Main results due
Dec 2009
Finished
Mar 2010