Electroacupuncture Regulation of Immune Cells in Herpes Zoster

February 1, 2026 updated by: Yan Shi, First People's Hospital of Hangzhou

The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster

Herpes Zoster (HZ), caused by the Varicella-Zoster Virus (VZV), is a common infection characterized by localized pain and blistering, with higher incidence in females. HZ affects patients' physical health, mental well-being, and quality of life. The immune system is critical in HZ pathogenesis. Studies show acupuncture relieves pain, modulates immunity, and may lower postherpetic neuralgia (PHN) risk. However, evidence is limited on whether electroacupuncture (EA) alleviates HZ by modulating immune cells. Using mass cytometry (CyTOF), this study will analyze peripheral immune cell changes pre- and post-EA to explore its regulatory effects on HZ immunity. This study will recruit HZ patients and healthy controls (HC), dividing patients into medication-only and medication+EA groups to assess EA's potential immunomodulatory effects in HZ treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will enroll 8 HZ patients who meet the inclusion criteria and 3 age- and gender-matched healthy controls (HC). HZ patients will be randomly assigned in a 1:1 ratio to a medication-only group or a medication plus electroacupuncture group. All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets. HZ-related immune cells in peripheral blood will be analyzed using CyTOF before treatment (day 0), during treatment (day 4), and after treatment (day 7). Pain intensity and characteristics will be assessed using the Visual Analogue Scale (VAS) and the Douleur Neuropathique 4 (DN4) questionnaire. Lesion healing (time to vesicle cessation, crusting, and scab detachment) and adverse events will also be recorded to evaluate lesion regression in HZ patients.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310053
        • Recruiting
        • The Affiliated Hangzhou First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for HZ:

  • Meets HZ diagnostic criteria;
  • Female, aged between 50 and 70 years;
  • Disease duration ≤7 days, with no prior antiviral, analgesic, or other treatments;
  • Herpetic lesions limited to the trunk, within 1 to 3 dermatomes;
  • Willing to participate in the trial and has signed the informed consent form.

Inclusion Criteria for HC:

  • No history of HZ or major cardiovascular, respiratory, digestive, urinary, hematologic, endocrine, or neurological diseases;
  • Age-matched female HC volunteers for the HZ group;
  • Clear consciousness and ability to communicate normally;
  • Fully understands the study protocol, demonstrates good compliance, and is willing to cooperate with the study;
  • Has signed a written informed consent form.

Exclusion Criteria:

  • Special types of herpes zoster, including ophthalmic, otic, visceral, meningeal herpes zoster, and zoster sine herpete;
  • Women who are planning to conceive, pregnant, or breastfeeding;
  • Patients with severe primary diseases of the circulatory, respiratory, or endocrine systems, or systemic failure;
  • Patients with bleeding tendencies;
  • Use of corticosteroids or immunosuppressants within the past month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug group
Control group
Drug: Drug
1) Valacyclovir Hydrochloride tablets, 0.3 g per dose, twice daily; 2) Mecobalamin tablets, 0.5 mg, three times daily. Taken continuously for 7 days.The affected skin is kept clean and protected to maintain lesion integrity.
Other Names:
  • Medication
Experimental: Drugs combined with electroacupuncture group
Observation group
Drug: Drug
1) Valacyclovir Hydrochloride tablets, 0.3 g per dose, twice daily; 2) Mecobalamin tablets, 0.5 mg, three times daily. Taken continuously for 7 days.The affected skin is kept clean and protected to maintain lesion integrity.
Other Names:
  • Medication
Procedure: Electroacupuncture
Electroacupuncture Treatment: Needling acupoints include the Jiaji points corresponding to the spinal nerve segment of the affected area, Ashi acupoints along the affected zone, and bilateral Hegu and Waiguan points. Electroacupuncture will be performed once daily for 30 minutes per session, with a total of 7 consecutive sessions. The Jiaji and Ashi acupoints will be connected to an electroacupuncture device, set to disperse-dense wave stimulation at a frequency of 2/100 Hz, with current intensity adjusted to the patient's tolerance level.
Other Names:
  • EA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood immune cell levels
Time Frame: Before (Day 0), during (Day 4) and after (Day 7) treatment.
1. Custom Detection Panel: A 42-color detection panel is specifically designed according to the study objectives and target cell subpopulations. 2. Sample Collection and Processing: Peripheral blood (5 ml) is collected from patients into EDTA purple-top anticoagulant tubes, stored/transported at 4°C, and processed within 48 hours using Ficoll to isolate the PBMC layer, yielding a single-cell suspension of PBMCs. PBMCs can be cryopreserved for batch analysis or processed fresh for immediate analysis. 3. Staining and Analysis: Samples are stained and analyzed over two days. Surface antibodies are stained on the first day, followed by membrane permeabilization and intracellular antibody staining on the second day, before proceeding with CyTOF analysis.
Before (Day 0), during (Day 4) and after (Day 7) treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
The Visual Analogue Scale (VAS) is used to assess pain and is widely applied in clinical practice in China. The basic method involves a 10 cm sliding ruler with one side marked with 10 increments. One end is labeled "0," indicating no pain, and the other end is labeled "10," representing the most intense, unbearable pain.
Before treatment (Day 0) and after each treatment (Day 1- Day 7).
Douleur Neuropathique 4 questions
Time Frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
The DN4 questionnaire consists of 10 items, with 7 items describing symptoms and 3 items related to clinical examination. Symptom descriptions include burning pain, cold pain, electric shock pain, tingling, pins and needles, numbness, and itching. Clinical examination includes decreased touch sensation, decreased pinprick sensation, and whether brushing in the painful area triggers or increases pain. Each item has "Yes" and "No" options, with "Yes" scored as 1 and "No" scored as 0, for a total score of 10. A score of ≥4 indicates a diagnosis of neuropathic pain.
Before treatment (Day 0) and after each treatment (Day 1- Day 7).
Lesion Regression Time
Time Frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
The time for blister cessation, crusting, and scab shedding is recorded.
Before treatment (Day 0) and after each treatment (Day 1- Day 7).
Occurrence of adverse reactions
Time Frame: During the intervention.
Record the occurrence of adverse reactions.
During the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 12, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZN-2024349-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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