Herpes ZosterNCT07361796
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
A study testing Venlafaxine combined conventional therapy and Conventional therapy in people with Herpes Zoster and Pain, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Pain, Postherpetic Neuralgia
- What is being tested?
- Venlafaxine combined conventional therapy and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ages more than 18 years;
- 2. Patients with onset of HZ rash less than 30 days;
- 3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
- 4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- 5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- 6. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Who cannot join
- 1. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;
- 2.Known hypersensitivity to venlafaxine;
- 3. Previous antiviral treatment that did not comply with guideline recommendations;
- 4. History of herpes zoster vaccination before enrollment;
- 5.History of major depressive disorder requiring antidepressant therapy;
- 6.History of systemic immune diseases, organ transplantation, or cancers;
- 7.Pregnancy or lactation;
- 8.Presence of acute or chronic pain disorders other than HZ.
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
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing
Fang Luo, 13611326978, 13611326978@163.com
About this study
Official title: The Analgesic Efficacy and Safety of Oral Medications (Venlafaxine) for Prevention of Postherpetic Neuralgia in Acute Herpes Zoster
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.
- Conditions
- Herpes Zoster, Pain, Postherpetic Neuralgia
- Being tested
- Venlafaxine combined conventional therapy, Conventional therapy
- Medical subject headings
- Herpes Zoster, Pain, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine combined conventional therapyDrug
Venlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.
The control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine combined with conventional therapy group | Experimental | Not described Receives: Drug: Venlafaxine combined conventional therapy |
| Conventional therapy group | Active comparator | Not described Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PHN
PHN will be defined as persistent pain in the affected dermatome at 90 days after rash onset that is clinically meaningful, operationalized as an average pain score ≥ 3 on the NRS.
Measured: at 90 days after rash onset
Secondary outcomes (9)
The average daily pain intensity
The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52
The worst numeric rating scale score
The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52
Proportion of Patients Achieving Pain Reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52
Average weekly consumption of each analgesic class
Measured: at weeks 4, 8, 12, 24, and 52
Herpes Zoster Severity of Illness Index
The HZSOI is a severity-by-duration measure of overall pain burden associated with HZ and is typically calculated as the area under the curve of the worst pain scores over a defined period after rash onset.
Measured: at weeks 1, 2, 4, 8 and 12
The 12-item Short-Form Health Survey (SF-12) score
The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.
Measured: at weeks 4, 8, 12, 24, and 52
The Medical Outcomes Study Sleep Scale (MOS)
The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).
Measured: at weeks 4, 8, 12, 24, and 52
Neuropathic Pain Scale
Neuropathic pain characteristics will be assessed using the Neuropathic Pain Scale in participants with developing PHN. The Neuropathic Pain Scale consists of 10 numeric rating items, each scored from 0 to 10, with higher scores indicating greater neuropathic pain severity. The scale assesses pain intensity, unpleasantness, and 8 specific pain qualities, including sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain.
Measured: at or after 90 days following rash onset
Adverse events
The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.
Measured: Through study completion, an average of 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Zhongnan Hospital, Jilin Provincial People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361796
- Sponsor's protocol ID
- KY2025-369-02-3
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Publications
Xing Y, Liu M, Ren F, Feng X, Zhao C, Luo F, Wu D. Venlafaxine for the Prevention of Postherpetic Neuralgia in Patients with Acute Herpes Zoster: Protocol for a Randomized Controlled Trial. J Pain Res. 2026 Sep 16;19:630923. doi: 10.2147/JPR.S630923. eCollection 2026.
PubMed 42765056
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy and Safety of Oral Medications (Venlafaxine) for Prevention of Postherpetic Neuralgia in Acute Herpes Zoster
- ClinicalTrials.gov ID
- NCT07361796
- Acronym / sponsor ID
- KY2025-369-02-3
- Conditions
- Herpes Zoster, Pain, Postherpetic Neuralgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Zhongnan Hospital, Jilin Provincial People's Hospital
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 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.
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine combined with conventional therapy group | Experimental | Drug: Venlafaxine combined conventional therapy |
| Conventional therapy group | Active comparator | Drug: Conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Ages more than 18 years;
- 2. Patients with onset of HZ rash less than 30 days;
- 3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
- 4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- 5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
Key exclusion criteria (8 listed)
- 1. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;
- 2.Known hypersensitivity to venlafaxine;
- 3. Previous antiviral treatment that did not comply with guideline recommendations;
- 4. History of herpes zoster vaccination before enrollment;
- 5.History of major depressive disorder requiring antidepressant therapy;
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 |
|---|---|---|
| Venlafaxine combined conventional therapyVenlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated. | Drug | Venlafaxine combined with conventional therapy group |
| Conventional therapyThe control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated. | Drug | Conventional therapy group |
Primary outcome
Incidence of PHN
Time frame: at 90 days after rash onset
PHN will be defined as persistent pain in the affected dermatome at 90 days after rash onset that is clinically meaningful, operationalized as an average pain score ≥ 3 on the NRS.
9 secondary outcomes
The average daily pain intensity
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52
The worst numeric rating scale score
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52
Proportion of Patients Achieving Pain Reduction
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52
Average weekly consumption of each analgesic class
Time frame: at weeks 4, 8, 12, 24, and 52
Herpes Zoster Severity of Illness Index
Time frame: at weeks 1, 2, 4, 8 and 12
The 12-item Short-Form Health Survey (SF-12) score
Time frame: at weeks 4, 8, 12, 24, and 52
The Medical Outcomes Study Sleep Scale (MOS)
Time frame: at weeks 4, 8, 12, 24, and 52
Neuropathic Pain Scale
Time frame: at or after 90 days following rash onset
Adverse events
Time frame: Through study completion, an average of 52 weeks
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 2 Sep 2026.
- Derived from this study: PubMed 42765056Xing Y, Liu M, Ren F, Feng X, Zhao C, Luo F, Wu D. Venlafaxine for the Prevention of Postherpetic Neuralgia in Patients with Acute Herpes Zoster: Protocol for a Randomized Controlled Trial. J Pain Res. 2026 Sep 16;19:630923. doi: 10.2147/JPR.S630923. eCollection 2026.
- Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.Link provided by the sponsor.
- Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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 Venlafaxine combined conventional therapy and Conventional therapy in people with Herpes Zoster and Pain, run by Beijing Tiantan Hospital 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 6 inclusion and 8 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 2 Sep 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. 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 Fang Luo (13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PHN (time frame: at 90 days after rash onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07361796, which also lists 1 linked publication.
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 2 Sep 2026.