UrticariaNCT06859736
Survey on the Characteristics of Traditional Medicine Syndromes in Urticaria Patients At Le Van Thinh Hospital
An observational study of Urticaria, run by Do Thanh Sang.
Trial summary
This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in urticaria patients at Le Van Thinh Hospital. Urticaria is a common dermatological condition that significantly impacts patients' quality of life. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Urticaria
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will recruit patients diagnosed with acute or chronic urticaria at Le Van Thinh Hospital, Vietnam. The study population will include adult patients (≥15 years old) who meet the eligibility criteria. The focus of the study is to classify Traditional Medicine (TM) syndromes in urticaria patients and explore their association with disease severity. Participants will undergo TM-based diagnostic assessment to determine the prevalence of TM syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind
Who may be able to join
- Patients aged 15 years or older.
- Diagnosed with acute or chronic urticaria based on modern medical criteria.
- Willing to participate and provide informed consent.
Who cannot join
- Patients with other dermatological conditions that may interfere with the diagnosis of urticaria.
- Patients currently using medications that may alter symptom presentation (e.g., antihistamines, corticosteroids, immunosuppressants).
- Patients who refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in urticaria patients at Le Van Thinh Hospital. Urticaria is a common dermatological condition that significantly impacts patients' quality of life. However, there is limited research on TM syndrome classification in this patient group. The study will collect data on symptoms, TM syndromes, and disease severity to determine common syndromes and their associations with clinical manifestations.
The study will be conducted as a cross-sectional, observational study with an estimated 200 participants. Eligible patients are those aged 18 years or older, diagnosed with acute or chronic urticaria, and willing to participate. The primary outcomes include the prevalence of TM syndromes, itching severity measured by the Visual Analogue Scale (VAS), and the correlation between TM syndromes and itching severity.
The study is approved by the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.
- Conditions
- Urticaria
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urticaria Patients with Traditional Medicine Syndrome Classification | This cohort includes patients diagnosed with acute or chronic urticaria who will be classified based on Traditional Medicine (TM) syndromes. Patients will be assessed using TM diagnostic criteria, including syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind. The study aims to evaluate the prevalence of these syndromes and their correlation with itching severity measured by the Visual Analogue Scale (VAS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Traditional Medicine Syndromes in Urticaria Patients
The study aims to determine the prevalence of Traditional Medicine (TM) syndromes in patients diagnosed with acute or chronic urticaria. Patients will be classified based on TM diagnostic criteria, including Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind. The percentage of patients presenting with each syndrome will be calculated.
Measured: At the time of patient enrollment (Baseline assessment, within the first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies 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
- 150 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
- NCT06859736
- Sponsor's protocol ID
- 241047 - ĐHYD
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 5 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Characteristics of Traditional Medicine Syndromes in Urticaria Patients At Le Van Thinh Hospital
- ClinicalTrials.gov ID
- NCT06859736
- Acronym / sponsor ID
- 241047 - ĐHYD
- Conditions
- Urticaria
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Do Thanh SangUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 5 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 aims to investigate the characteristics of Traditional Medicine (TM) syndromes in urticaria patients at Le Van Thinh Hospital. Urticaria is a common dermatological condition that significantly impacts patients' quality of life. However, there is limited research on TM syndrome classification in this patient group. The study will collect data on symptoms, TM syndromes, and disease severity to determine common syndromes and their associations with clinical manifestations.
The study will be conducted as a cross-sectional, observational study with an estimated 200 participants. Eligible patients are those aged 18 years or older, diagnosed with acute or chronic urticaria, and willing to participate. The primary outcomes include the prevalence of TM syndromes, itching severity measured by the Visual Analogue Scale (VAS), and the correlation between TM syndromes and itching severity.
The study is approved by the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urticaria Patients with Traditional Medicine Syndrome Classification | – | –This cohort includes patients diagnosed with acute or chronic urticaria who will be classified based on Traditional Medicine (TM) syndromes. Patients will be assessed using TM diagnostic criteria, including syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind. The study aims to evaluate the prevalence of these syndromes and their correlation with itching severity measured by the Visual Analogue Scale (VAS). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will recruit patients diagnosed with acute or chronic urticaria at Le Van Thinh Hospital, Vietnam. The study population will include adult patients (≥15 years old) who meet the eligibility criteria. The focus of the study is to classify Traditional Medicine (TM) syndromes in urticaria patients and explore their association with disease severity. Participants will undergo TM-based diagnostic assessment to determine the prevalence of TM syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind
Key inclusion criteria (3 listed)
- Patients aged 15 years or older.
- Diagnosed with acute or chronic urticaria based on modern medical criteria.
- Willing to participate and provide informed consent.
Key exclusion criteria (3 listed)
- Patients with other dermatological conditions that may interfere with the diagnosis of urticaria.
- Patients currently using medications that may alter symptom presentation (e.g., antihistamines, corticosteroids, immunosuppressants).
- Patients who refuse to participate in the study
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
Prevalence of Traditional Medicine Syndromes in Urticaria Patients
Time frame: At the time of patient enrollment (Baseline assessment, within the first visit)
The study aims to determine the prevalence of Traditional Medicine (TM) syndromes in patients diagnosed with acute or chronic urticaria. Patients will be classified based on TM diagnostic criteria, including Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind. The percentage of patients presenting with each syndrome will be calculated.
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 5 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urticaria, run by Do Thanh Sang.
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 3 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Sang Do, MD (+84 0948561030, dtsang@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Traditional Medicine Syndromes in Urticaria Patients (time frame: At the time of patient enrollment (Baseline assessment, within the first visit)). 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 5 Mar 2025.