Clinical trial NCT06643247: Electroacupuncture Regulation of Immune Cells in Herpes Zoster
Official title: The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Herpes Zoster
Electroacupuncture
Immune
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 8
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Peripheral blood immune cell levels
timeFrame: Before (Day 0), during (Day 4) and after (Day 7) treatment.
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
measure: Douleur Neuropathique 4 questions
timeFrame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
measure: Lesion Regression Time
timeFrame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).
measure: Occurrence of adverse reactions
timeFrame: During the intervention.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: