This multicenter RCT aims to compare the efficacy and safety of Brivudine versus Famciclovir in treating acute herpes zoster. Primary objective: Evaluate pain reduction via Numeric Pain Rating Scale (NPRS) at Day 30. Secondary objectives: Compare NPRS at Day 3/Day 7/Day 14/Day 90, time to lesion resolution, Postherpetic Neuralgia (PHN) incidence, and safety.
A randomized controlled trial enrolling 140 participants from 5 centers in China. Patients receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days. Follow-ups occur at Day 3, Day 7, Day 14, Day 30, Day 90. Primary endpoint: Numeric Pain Rating Scale (NPRS) at Day 30; secondary endpoints: NPRS at other timepoints, lesion healing time, Postherpetic Neuralgia (PHN) rate, and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
brivudine 125 mg per dose, once daily, 7 days
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
Peking University Third Hospital
Beijing, China
RECRUITINGBeijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGDay 30 numeric pain rating scale (NPRS)
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame: Day 30
numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame: Day 3, Day 7, Day 14, Day 90
Incidence of PHN
Incidence of Postherpetic Neuralgia
Time frame: Day 90
skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90
whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
Time frame: Day 3, Day 7, Day 14, Day 30, Day 90
Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90
Percentage of body surface area (BSA%) affected by lesions on Day 3, Day 7, Day 14, Day 30 and Day 90
Time frame: Day 3, Day 7, Day 14, Day 30 and Day 90
cessation of new lesion formation
whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90
Time frame: Day 3, Day 7, Day 14, Day 30 and Day 90
complete crusting of all lesions
whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90
Time frame: Day 3, Day 7, Day 14, Day 30 and Day 90
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Xuanwu Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGAdverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days
Time frame: From baseline to Day 30