Acute Herpes ZosterNCT07515885
Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker Evaluation
A study testing Acupuncture and Valacyclovir, pregabalin and mecobalamin in people with Acute Herpes Zoster, run by Dexiong Han at 1 site in China.
Trial summary
Background: Herpes zoster (HZ) is an acute dermatological condition caused by the varicella-zoster virus. Its onset is characterized by severe pain, imposing significant physical and psychological burdens on patients. Acupuncture offers distinct advantages in treating acute herpes zoster and associated pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Herpes Zoster
- What is being tested?
- Acupuncture and Valacyclovir, pregabalin and mecobalamin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria for acute HZ27 and skin symptom appears less than 7 days;
- Only have lesions in the trunk and limbs;
- 2. Patients with a Numerical Rating Scale (NRS) score ≥ 4; 3. Aged between 20 and 80 years; 4. Patients voluntarily participate in the trial and are willing to sign the informed consent.
Who cannot join
- Special types of HZ that occur in head, eyes, viscera, etc. or those combined with other skin diseases;
- Has received relevant treatment and it may affect the observation indicators;
- Pregnant and lactating women;
- Patients who are allergic to iodophor or other topical disinfectants, or a history of sudden, potentially life-threatening systemic allergic reactions;
- Those who are afraid of acupuncture or have metal implants and are not suitable for EA treatment;
- Those with contraindications to pregabalin such as congestive heart disease and heart failure;
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- Patients with severe primary diseases such as liver, kidney, cardiovascular and cerebrovascular, metabolic, autoimmune system diseases, malignant tumors, etc., and those with mental illness;
- Patients who have hematologic diseases or coagulation disorders;
- Patients who are currently participating in other clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Dexiong Han, PHD, 86+18958077903, 20105015@zcmu.edu.cn
Xiaoqi Ying, master, 86+13858185657, yingxiaoqi2023@163.com
About this study
Official title: Research on the Therapeutic Effect of Electroacupuncture on Acute Herpes Zoster-Associated Pain and Its Anti-inflammatory Injury Mechanism
Background: Herpes zoster (HZ) is an acute dermatological condition caused by the varicella-zoster virus. Its onset is characterized by severe pain, imposing significant physical and psychological burdens on patients. Acupuncture offers distinct advantages in treating acute herpes zoster and associated pain. However, the therapeutic efficacy of electroacupuncture for acute herpes zoster, its potential to reduce PHN incidence, and the role of biomarkers in predicting PHN incidence require further clinical validation.
Methods: A total of 228 patients with acute herpes zoster will be recruited from 3 hospitals and randomly assigned to EA group or medication-alone group or sham acupuncture group in a 1:1:1 ratio, utilizing multicenter stratified block randomization. The trial will involve a 2 week treatment period, and a 3-month follow-up period. All variables will be evaluated at week 0, week 1, week 2, and on the 90th day after rash onset. All participants will continue antiviral medication treatment. Primary outcome is Numerical Rating Scale; secondary outcomes include herpes lesion crusting time, pain episodes within a 24-hour period, Hamilton Anxiety Scale, Hamilton Depression Scale, 36-Item Short Form Health Survey, changes of biomarkers (Erythrocyte sedimentation rate, C-reactive protein, Tumor Necrosis Factor-α, Interleukin-10, Substance P and neuropeptide Y) and PHN incidence rate. All adverse effects will be assessed during the trial.
Conclusion: This study will elucidate the efficacy of electroacupuncture in treating acute herpes zoster, whether electroacupuncture can reduce the incidence of PHN, and the role of biomarkers in predicting the incidence of PHN.
- Conditions
- Acute Herpes Zoster
- Being tested
- Acupuncture, Sham, Valacyclovir, pregabalin and mecobalamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
EA will be applied at Ashi points (sites of severe pain in herpetic lesions) and Jiaji points (EX-B2) on the affected side.All participants will undergo a 2-week treatment. Acupuncture will be performed thrice a week.A dense-disperse wave (2/100 Hz) will be used
ShamProcedure or surgery
non-penetrating placebo acupuncture
Valacyclovir, pregabalin and mecobalaminDrug
Antiviral therapy: The main treatment is with valacyclovir (oral, 1000 mg, three times daily, for 7 days). In patients with non-severe hepatic or renal impairment, or other conditions that require dose adjustment, the antiviral regimen (dose or drug choice) should be modified according to the Chinese Consensus on the Diagnosis and Management of Herpes Zoster (2022).
Antineuralgic therapy: Pregabalin (oral, 75 mg, two times daily throughout the trial).
Neurotrophic therapy: Mecobalamin (oral, 0.5 mg, three times daily throughout the trial)
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | Not described Receives: Procedure: Acupuncture; Drug: Valacyclovir, pregabalin and mecobalamin |
| sham acupuncture group | Placebo comparator | Not described Receives: Procedure: Sham; Drug: Valacyclovir, pregabalin and mecobalamin |
| Medication-Alone Group | Placebo comparator | Not described Receives: Drug: Valacyclovir, pregabalin and mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')
Measured: week 0, 1, 2, 13
Secondary outcomes (12)
Pain episodes
Measured: week0,1,2
Crusting Time
Measured: week2
HAMA
Measured: week0,1,2
HAMD
Measured: week0,1,2
SF-36
Measured: week0,1,2
ESR
Measured: week0,1,2
CRP
Measured: week0,1,2
TNF-α
Measured: week0,1,2
IL-10
Measured: week0,1,2
SP
Measured: week0,1,2
NPY
Measured: week0,1,2
PHN incidence
Measured: week13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dexiong Han
- Sponsor type
- Other government
- Collaborators
- The Third People's Hospital of Hangzhou, Changxing County Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Dexiong Han, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515885
- Sponsor's protocol ID
- ZSLL-KY-2025-052-01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No