Urticaria is a common skin disorder and 15-25% of people experience at least one attack of urticaria during their lifetime. Urticaria can be divided into acute urticaria (AU) and chronic urticaria (CU). CU is more common in adults, and affects women more frequently than men. According to Chinese medicine (CM) theory, CU is known as Yin Zhen. Nowadays, CM is widely used for managing CU in Hong Kong and mainland. Among different Chinese herbal formulae for urticaria, Xiao-Feng Powder (XFP), also known as Wind-Dispersing Powder, is one of the most frequently used Chinese herbal formulae for CU.
This study used modified Xiao-Feng Powder (mXFP) to evaluate the effectiveness and safety of mXFP in treating CU. Hence, a double-blind, randomised, placebo-controlled clinical trial design with strong scientific rigor will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of mXFP for CU.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Both male and female;
. Age from 18 to 65 years;
. Documented history of CU for at least 6 weeks prior to entry in the study;
. Meet EAACI/GA2LEN/EDF/WAO 2017 guidelines, i.e. spontaneous appearance of wheals, angioedema or both for \> 6 weeks due to known or unknown causes;
. Symptom severity must be greater than 10 points (UAS7 score);
. Able to complete questionnaires and take medications as scheduled; and
. Agree to participate in the study and sign the informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Dual deficiency of Qi and blood according to Chinese medicine theory
. Urticaria is induced by physical factors (e.g., cold urticaria, delayed pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema) only;
. Known to have dermatological diseases with skin pruritus;
. Known to have any serious diseases such as cancer, severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma, severe mental disorders, leukemia, and acute infectious disease;
. Known to use oral/injectable corticosteroids, leukotriene inhibitors, immunosuppressants or other Chinese herbal medicine within one month of enrollment;
. Known to receive omalizumab, ligelizumab, or other experimental biologic for CU;
. Documented pregnancy or planning to conceive, breast-feeding women; or
. Operate heavy machinery or need to drive motor vehicles as an essential part of their profession.