ClinicalTrials.gg
RecruitingNCT07361796Updated Sep 2, 2026

The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster

An interventional study of Venlafaxine combined conventional therapy and Conventional therapy in Herpes Zoster, Pain and Postherpetic Neuralgia, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
832
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Herpes Zoster
  • Pain
  • Postherpetic Neuralgia
03

In context

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

This study's planned enrollment of 832 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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. and alanine aminotransferase levels less than twice the ;
  • 5. Estimated of 30 mL/min per 1.73 m2 or higher;
  • 6. Willing to sign the form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion criteria

Exclusion Criteria:

  • 1. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;
  • 2.Known 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
832 participants (estimated)

Study arms

  • Experimental
    Venlafaxine combined with conventional therapy group

    Drug: Venlafaxine combined conventional therapy

  • Active comparator
    Conventional therapy group

    Drug: Conventional therapy

Interventions

  • DrugVenlafaxine combined conventional therapy

    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.

  • DrugConventional therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at 90 days after rash onset

Secondary outcomes

  1. 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.

    Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52

  2. 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.

    Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52

  3. Proportion of Patients Achieving Pain Reduction

    The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

    Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52

  4. Average weekly consumption of each analgesic class

    Time frame: at weeks 4, 8, 12, 24, and 52

  5. 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.

    Time frame: at weeks 1, 2, 4, 8 and 12

  6. 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.

    Time frame: at weeks 4, 8, 12, 24, and 52

  7. 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).

    Time frame: at weeks 4, 8, 12, 24, and 52

  8. 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.

    Time frame: at or after 90 days following rash onset

  9. 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.

    Time frame: Through study completion, an average of 52 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07361796
Collaborators
Xiangya Hospital of Central South University, Zhongnan Hospital, Jilin Provincial People's Hospital
Responsible party
Fang Luo (Director, Department of Pain Management, Principal Investigator, Clinical Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Jan 23, 2026
Start date
Dec 15, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Fang Luo
Contact
13611326978@163.com
13611326978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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