Electroacupuncture Regulation of Immune Cells in Herpes Zoster

Zhejiang University

Status: Enrolling

Conditions: Immune; Electroacupuncture; Herpes Zoster

Treatments: Drug: Drug; Procedure: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06643247

ZN-2024349-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Drug group

Active Comparator group

Description:

Control group

Treatment:

Drug: Drug

Drugs combined with electroacupuncture group

Experimental group

Description:

Observation group

Treatment:

Procedure: Electroacupuncture

Drug: Drug