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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Therapeutic Effect of Electroacupuncture on Acute Herpes Zoster-Associated Pain and Its Anti-inflammatory Injury Mechanism
- ClinicalTrials.gov ID
- NCT07515885
- Acronym / sponsor ID
- ZSLL-KY-2025-052-01
- Conditions
- Acute Herpes Zoster
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Dexiong HanOther government
- Collaborators
- The Third People's Hospital of Hangzhou, Changxing County Hospital of Traditional Chinese Medicine
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Procedure: Acupuncture, Drug: Valacyclovir, pregabalin and mecobalamin |
| sham acupuncture group | Placebo comparator | Procedure: Sham, Drug: Valacyclovir, pregabalin and mecobalamin |
| Medication-Alone Group | Placebo comparator | Drug: Valacyclovir, pregabalin and mecobalamin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureEA 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 | Procedure or surgery | Electroacupuncture group |
| Shamnon-penetrating placebo acupuncture | Procedure or surgery | sham acupuncture group |
| Valacyclovir, pregabalin and mecobalaminAntiviral 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) | Drug | Electroacupuncture group, Medication-Alone Group, sham acupuncture group |
Primary outcome
Numerical Rating Scale
Time frame: week 0, 1, 2, 13
an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')
12 secondary outcomes
Pain episodes
Time frame: week0,1,2
Crusting Time
Time frame: week2
HAMA
Time frame: week0,1,2
HAMD
Time frame: week0,1,2
SF-36
Time frame: week0,1,2
ESR
Time frame: week0,1,2
CRP
Time frame: week0,1,2
TNF-α
Time frame: week0,1,2
IL-10
Time frame: week0,1,2
SP
Time frame: week0,1,2
NPY
Time frame: week0,1,2
PHN incidence
Time frame: week13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Valacyclovir, pregabalin and mecobalamin in people with Acute Herpes Zoster, run by Dexiong Han at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dexiong Han, PHD (86+18958077903, 20105015@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: week 0, 1, 2, 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.