- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870877
Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study
Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study Conducted At Le Van Thinh Hospital, Vietnam
Study Overview
Status
Detailed Description
This study is a cross-sectional and case series study conducted at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam, between January and June 2024. It aims to evaluate the correlation between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study includes 80 participants diagnosed with HZ, whose pain severity is assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. The participants are classified into TCM syndromes based on standard diagnostic criteria, including Liver Meridian Depression and Heat Syndrome (LMD), Spleen Deficiency and Dampness Retention Syndrome (SDA), and Qi Stagnation and Blood Stasis Syndrome (QSA).
The primary objectives of the study are:
To determine the prevalence of different TCM syndromes in HZ patients. To analyze the correlation between LANSS scores and specific TCM syndromes. To provide insights into the integration of objective neuropathic pain assessment tools with traditional diagnostic frameworks.
Data collection includes demographic characteristics, medical history, pain characteristics, TCM diagnostic features, and clinical examination results. Statistical analyses include correlation tests and multinomial logistic regression to assess the relationship between LANSS pain scores and TCM syndromes.
The study findings will contribute to a better understanding of the relationship between neuropathic pain and TCM syndromes in Herpes Zoster. The results may help refine diagnostic approaches and optimize integrative treatment strategies for pain management in patients with HZ.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Viet Nam
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Ho Chi Minh, Viet Nam, Vietnam, 700000
- Le Van Thinh Hospital
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Contact:
- Sang Do, MD
- Phone Number: +84 28 3896 9990
- Email: dtsang@ump.edu.vn
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Contact:
- Sang Do
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Clinically diagnosed with Herpes Zoster (HZ) based on European Consensus Guidelines
- Experiencing neuropathic pain associated with HZ
- Willing to provide informed consent
Exclusion Criteria:
- History of chronic pain conditions unrelated to HZ
- Receiving immunosuppressive therapy or diagnosed with immunodeficiency disorders
- Patients who had already received antiviral or analgesic treatment before evaluation
- Patients unable or unwilling to provide informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neuropathic Pain Severity in Herpes Zoster Patients
Time Frame: Baseline (Day 1)
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Measured using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale.
LANSS scores will be used to determine the severity of neuropathic pain in study participants.
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Baseline (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between Neuropathic Pain and Traditional Medicine Syndromes
Time Frame: Baseline (Day 1).
|
Analysis of LANSS scores and their association with Traditional Chinese Medicine (TCM) syndromes (Liver Meridian Depression and Heat Syndrome, Spleen Deficiency and Dampness Retention Syndrome, and Qi Stagnation and Blood Stasis Syndrome) using multinomial logistic regression.
|
Baseline (Day 1).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Varicella Zoster Virus Infection
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Infections
- Virus Diseases
- Peripheral Nervous System Diseases
- DNA Virus Infections
- Skin Diseases
- Skin Diseases, Infectious
- Herpesviridae Infections
- Skin Diseases, Viral
- Neuralgia
- Herpes Simplex
- Herpes Zoster
Other Study ID Numbers
- 78/HĐĐĐ-ĐHYD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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