Electroacupuncture Regulation of Immune Cells in Herpes Zoster

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Herpes Zoster Electroacupuncture Immune

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Drug group

Control group

Group Type ACTIVE_COMPARATOR

Drug

Intervention Type 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.

Drugs combined with electroacupuncture group

Observation group

Group Type EXPERIMENTAL

Drug

Intervention Type 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.

Electroacupuncture

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Medication EA

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes