Subcutaneous Calcitonin in Acute Herpes Zoster
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcitonin, Saline.
- Who it may be relevant to
- Registry conditions: Calcitonin, Subcutaneous, Acute Herpes Zoster. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
Overview
This prospective randomized controlled study will be conducted to evaluate the effect of adding calcitonin to the standard treatment protocol in patients with acute herpes zoster infection.
Detailed description
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.
Interventions
- Drug Calcitonin
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks - Other Saline
patients will receive subcutaneous saline (1 ml) daily for three weeks.
Primary outcome measures
- Incidence of postherpetic neuralgia at 3 months after rash onset. [Time frame: 3 months after onset of acute herpes zoster rash.]
Secondary outcome measures (4)
- Incidence of postherpetic neuralgia. [Time frame: 6 months after onset of acute herpes zoster rash.]
- Severity of acute herpes zoster pain. [Time frame: Up to 1 month after onset of acute herpes zoster rash.]
- Number of medications used to treat pain. [Time frame: up to 6 months after onset of acute herpes zoster rash.]
- Side effects [Time frame: Up to 1 month after onset of acute herpes zoster rash.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT07655804 · 36265PR14/4/26