The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Recent attention has focused on the potential role of muscle relaxant, which can relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions. Therefore, investigators hypothesize that baclofen may effectively reduce the severity of HZ pain without significantly increasing adverse events.
Eligibility criteria
Qualifiers
1. Ages more than 18 years;
2. Patients with onset of HZ rash less than 90 days;
3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
Disqualifiers
1. History of taking baclofen;
2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
3. History of intolerance or hypersensitivity to any active components or excipient of the baclofen;
4. History of systemic immune diseases, organ transplantation, or cancers;
Trial design
Treatments tested in this trial
- Baclofen combined conventional therapy
- Conventional therapy
Treatment groups
750 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov