Survey on the Characteristics of Traditional Medicine Syndromes in Urticaria Patients At Le Van Thinh Hospital

NCT06859736 | Not Yet Recruiting DMC

• 1 other identifier: 241047 - ĐHYD
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of patient enrollment (Baseline assessment, within the first visit)

Study Arms (1)

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).

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Patients aged 15 years or older.
• Diagnosed with acute or chronic urticaria based on modern medical criteria.
• Willing to participate and provide informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Do Thanh Sang: lead

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Sang Do, MD

CONTACT

+84 0948561030; dtsang@ump.edu.vn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University of Medicine and Pharmacy at Ho Chi Minh City

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02