NCT07515885

Brief Summary

Background: Herpes zoster (HZ) is an acute dermatological condition caused by the varicella-zoster virus. Its onset is characterized by severe pain, imposing significant physical and psychological burdens on patients. Acupuncture offers distinct advantages in treating acute herpes zoster and associated pain. However, the therapeutic efficacy of electroacupuncture for acute herpes zoster, its potential to reduce PHN incidence, and the role of biomarkers in predicting PHN incidence require further clinical validation. Methods: A total of 228 patients with acute herpes zoster will be recruited from 3 hospitals and randomly assigned to EA group or medication-alone group or sham acupuncture group in a 1:1:1 ratio, utilizing multicenter stratified block randomization. The trial will involve a 2 week treatment period, and a 3-month follow-up period. All variables will be evaluated at week 0, week 1, week 2, and on the 90th day after rash onset. All participants will continue antiviral medication treatment. Primary outcome is Numerical Rating Scale; secondary outcomes include herpes lesion crusting time, pain episodes within a 24-hour period, Hamilton Anxiety Scale, Hamilton Depression Scale, 36-Item Short Form Health Survey, changes of biomarkers (Erythrocyte sedimentation rate, C-reactive protein, Tumor Necrosis Factor-α, Interleukin-10, Substance P and neuropeptide Y) and PHN incidence rate. All adverse effects will be assessed during the trial. Conclusion: This study will elucidate the efficacy of electroacupuncture in treating acute herpes zoster, whether electroacupuncture can reduce the incidence of PHN, and the role of biomarkers in predicting the incidence of PHN.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Sep 2025Dec 2028

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

March 31, 2026

Last Update Submit

June 4, 2026

Conditions

Acute Herpes Zoster

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale

    an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')

    week 0, 1, 2, 13

Secondary Outcomes (12)

  • Pain episodes

    week0,1,2

  • Crusting Time

    week2

  • HAMA

    week0,1,2

  • HAMD

    week0,1,2

  • SF-36

    week0,1,2

  • +7 more secondary outcomes

Study Arms (3)

Electroacupuncture group

EXPERIMENTAL
Procedure: AcupunctureDrug: antiviral, antineuralgic, and neurotrophic therapies

sham acupuncture group

PLACEBO COMPARATOR
Procedure: ShamDrug: antiviral, antineuralgic, and neurotrophic therapies

Medication-Alone Group

PLACEBO COMPARATOR
Drug: antiviral, antineuralgic, and neurotrophic therapies

Interventions

AcupuncturePROCEDURE

EA will be applied at Ashi points (sites of severe pain in herpetic lesions) and Jiaji points (EX-B2) on the affected side.All participants will undergo a 2-week treatment. Acupuncture will be performed thrice a week.A dense-disperse wave (2/100 Hz) will be used

Electroacupuncture group
ShamPROCEDURE

non-penetrating placebo acupuncture

sham acupuncture group
antiviral, antineuralgic, and neurotrophic therapiesDRUG

Antiviral therapy: Follow the "Chinese consensus on the diagnosis and management of herpes zoster (2022)" to provide standardized antiviral treatment for the patients. Antineuralgic therapy: Pregabalin (oral, 75 mg, twice daily throughout the trial). Neurotrophic therapy: Mecobalamin (oral, 0.5 mg, triple daily throughout the trial)

Electroacupuncture groupMedication-Alone Groupsham acupuncture group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet the diagnostic criteria for acute HZ27 and skin symptom appears less than 7 days;
  • Only have lesions in the trunk and limbs;
  • \. Patients with a Numerical Rating Scale (NRS) score ≥ 4; 3. Aged between 20 and 80 years; 4. Patients voluntarily participate in the trial and are willing to sign the informed consent.

You may not qualify if:

  • Special types of HZ that occur in head, eyes, viscera, etc. or those combined with other skin diseases;
  • Has received relevant treatment and it may affect the observation indicators;
  • Pregnant and lactating women;
  • Patients who are allergic to iodophor or other topical disinfectants, or a history of sudden, potentially life-threatening systemic allergic reactions;
  • Those who are afraid of acupuncture or have metal implants and are not suitable for EA treatment;
  • Those with contraindications to pregabalin such as congestive heart disease and heart failure;
  • Patients with severe primary diseases such as liver, kidney, cardiovascular and cerebrovascular, metabolic, autoimmune system diseases, malignant tumors, etc., and those with mental illness;
  • Patients who have hematologic diseases or coagulation disorders;
  • Patients who are currently participating in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapysalicylhydroxamic acidAntiviral Agents

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Dexiong Han, PHD

CONTACT

86+1895807790320105015@zcmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief TCM Physician

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 9, 2026

Record last verified: 2026-03

Locations

CN(1)