Electroacupuncture Regulation of Immune Cells in Herpes Zoster

NCT06643247 | Recruiting

• 1 other identifier: ZN-2024349-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Zoster; Electroacupuncture; Immune

Outcome Measures

Primary Outcomes (1)

• Peripheral blood immune cell levels

  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 Outcomes (4)

• Visual Analogue Scale

  Before treatment (Day 0) and after each treatment (Day 1- Day 7).

• Douleur Neuropathique 4 questions

  Before treatment (Day 0) and after each treatment (Day 1- Day 7).

• Lesion Regression Time

  Before treatment (Day 0) and after each treatment (Day 1- Day 7).

• Occurrence of adverse reactions

  During the intervention.

Study Arms (2)

Drug group

ACTIVE COMPARATOR

Control group

Drug: Drug

Drugs combined with electroacupuncture group

EXPERIMENTAL

Observation group

Drug: Drug; Procedure: Electroacupuncture

Interventions

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.

Also known as: Medication

Drug group; Drugs combined with electroacupuncture group

Electroacupuncture 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.

Also known as: EA

Drugs combined with electroacupuncture group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310053, China

RECRUITING

MeSH Terms

Conditions

Herpes Zoster

Interventions

Pharmaceutical Preparations; Dosage Forms; Electroacupuncture

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Yan Shi

CONTACT

13867439433; tumingqi1230@163.com

Mingqi Tu

CONTACT

15700067213; 403712321@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 16, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)