Herpes Zoster (HZ)NCT06870877
Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study
An observational study of Herpes Zoster (HZ) and Traditional Chinese Medicine (TCM), run by Do Thanh Sang at 1 site in Vietnam.
Trial summary
This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster (HZ), Traditional Chinese Medicine (TCM)
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Feb 2025to 12 May 2025
- Phase
- Observational
- 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
Study population: The study population consists of 80 adult patients diagnosed with Herpes Zoster (shingles) who presented at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. These patients were experiencing neuropathic pain and were assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. Participants were classified into Traditional Chinese Medicine (TCM) syndromes based on diagnostic criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Le Van Thinh Hospital
Ho Chi Minh City, Viet Nam, 700000
Sang Do, MD, +84 28 3896 9990, dtsang@ump.edu.vn
Sang Do
About this study
Official title: Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study Conducted At Le Van Thinh Hospital, Vietnam
This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM diagnostic classifications to enhance individualized treatment strategies. Conducted at Le Van Thinh Hospital, Vietnam, this cross-sectional study includes 80 HZ patients, assessing their pain levels and corresponding TCM syndromes. The findings will contribute to a more comprehensive approach to pain management in Herpes Zoster.
Read the 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.
- Medical subject headings
- Herpes Zoster
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Severity in Herpes Zoster Patients
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.
Measured: Baseline (Day 1)
Secondary outcomes (1)
Correlation Between Neuropathic Pain and Traditional Medicine Syndromes
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.
Measured: Baseline (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start28 Feb 2025 (estimated)
- Primary completion12 May 2025 (estimated)
- Study completion12 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Zoster (HZ)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Do Thanh Sang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Do Thanh Sang, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870877
- Sponsor's protocol ID
- 78/HĐĐĐ-ĐHYD
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study Conducted At Le Van Thinh Hospital, Vietnam
- ClinicalTrials.gov ID
- NCT06870877
- Acronym / sponsor ID
- 78/HĐĐĐ-ĐHYD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Do Thanh SangUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 12 May 2025 (estimated)
- Study completion
- 12 May 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM diagnostic classifications to enhance individualized treatment strategies. Conducted at Le Van Thinh Hospital, Vietnam, this cross-sectional study includes 80 HZ patients, assessing their pain levels and corresponding TCM syndromes. The findings will contribute to a more comprehensive approach to pain management in Herpes Zoster.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 80 adult patients diagnosed with Herpes Zoster (shingles) who presented at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. These patients were experiencing neuropathic pain and were assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. Participants were classified into Traditional Chinese Medicine (TCM) syndromes based on diagnostic criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropathic Pain Severity in Herpes Zoster Patients
Time frame: Baseline (Day 1)
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.
1 secondary outcome
Correlation Between Neuropathic Pain and Traditional Medicine Syndromes
Time frame: Baseline (Day 1).
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Herpes Zoster (HZ) and Traditional Chinese Medicine (TCM), run by Do Thanh Sang at 1 site in Vietnam.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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 Vietnam. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Severity in Herpes Zoster Patients (time frame: Baseline (Day 1)). 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 11 Mar 2025.