Subcutaneous Calcitonin in Acute Herpes Zoster

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients aged ≥ 50 years, with acute herpes zoster infection (rash duration < 7 days) and moderate to severe pain.

Disqualifiers

Coagulation abnormalities

Pre-existing other pain syndrome or psychological disorders.

Severe hepatic, cardiovascular, or renal disorders.

Allergy to calcitonin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcitonin

    Drug

    patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks

  • Saline

    Other intervention

    patients will receive subcutaneous saline (1 ml) daily for three weeks.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Calcitonin groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postherpetic neuralgia at 3 months after rash onset.

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.

Time frame
3 months after onset of acute herpes zoster rash.

Secondary outcomes

1

Incidence of postherpetic neuralgia.

Pain score more than 3.

Time frame
6 months after onset of acute herpes zoster rash.
2

Severity of acute herpes zoster pain.

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.

Time frame
Up to 1 month after onset of acute herpes zoster rash.
3

Number of medications used to treat pain.

Analgesics, anti-neuropathic pain medications and opioids will be recorded.

Time frame
up to 6 months after onset of acute herpes zoster rash.
4

Side effects

Vomiting

Time frame
Up to 1 month after onset of acute herpes zoster rash.

Other outcomes

Sponsors and contacts

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