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Chronic UrticariaPhase 2NCT04967092

Modified Xiao-Feng Powder for Chronic Urticaria

A Phase 2 study testing Modified Xiao-Feng Powder + Antiallergics in people with Chronic Urticaria, run by Prof. Lin Zhixiu at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Urticaria
What is being tested?
Modified Xiao-Feng Powder + Antiallergics
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteHong Kong
Study dates
15 Aug 2021to 7 Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.
  • Know recent history (within previous 12 months) of drug addiction or alcohol abuse.
  • Involved in other interventional clinical studies at the same time.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

About this study

Official title: Efficacy and Safety of Modified Xiao-Feng Powder in the Treatment of Chronic Urticaria - A Double-Blind Randomized Placebo-Controlled Study

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.

Read the detailed description

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) according to the disease duration. CU is classified as either chronic autoimmune urticaria or chronic idiopathic urticaria.

In Chinese medicine theory, Urticaria is usually associated with either internal or external wind pathogen. Wind as a pathogenic factor is characterized by sudden onset and rapid changes in symptoms, and when resulting from an internal deficiency, it often leads to dryness.

Several research groups have conducted clinical studies to evaluate the efficacy of Chinese herbal medicine for the treatment of CU in recent decades. 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, also has been widely used in Chinese medicine dermatology to expel wind and eliminate dampness, clear heat, nourish the blood and stop itchiness. Moreover, other researchers have found that XFP is effective in inhibiting inflammation, allergy, and oxidative stress in allergic skin diseases.

Investigators hypothesize that mXFP is effective and safe for the treatment of CU. In this study, eligible subjects will be randomized to receive either mXFP or placebo twice daily for 12 weeks followed by post-treatment visits at week 16. Subjects will take the standard therapy of antihistamines regularly for the first 6 weeks and then on on-demand basis for the next 6 weeks during the treatment period.

Being tested
Modified Xiao-Feng Powder + Antiallergics, Placebo + Antiallergics
Keywords
Chronic Urticaria, Chinese Medicines
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Xiao-Feng Powder + AntiallergicsDrug

    Modified Xiao-Feng Powder granules twice daily for 12 weeks plus Bilastine 20mg once daily for the first 6 weeks, and on-demand for the following 6 weeks.

  • Placebo + AntiallergicsOther

    Placebo granules twice daily for 12 weeks plus Bilastine 20mg once daily for the first 6 weeks, and on-demand for the following 6 weeks.

Study groups in NCT04967092
Study groupRoleWhat they receive
Modified Xiao-Feng PowderActive comparatorModified Xiao-Feng Powder granules will be taken twice daily for 12 weeks
Receives: Drug: Modified Xiao-Feng Powder + Antiallergics
PlaceboPlacebo comparatorPlacebo granules will be taken twice daily for 12 weeks
Receives: Other: Placebo + Antiallergics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Urticaria Activity Score (UAS7)

    The UAS combines daily wheal numbers (0 = none, 1 = < 20 wheals/24 h, 2 = 20-50 wheals/24 h, and 3= > 50 wheals/24 h or large confluent areas of wheals), and pruritus intensity (0 = none, 1 = present but not annoying or troublesome, 2 = troublesome but does not interfere with normal daily activity or sleep, and 3 = severe pruritus, which is sufficiently troublesome to interfere with normal daily activity or sleep). The score ranges from 0 to 42 weekly. The highest score, the more severe of urticaria activity.

    Measured: 12 weeks

Secondary outcomes (8)

  1. Change of Urticaria Activity Score (UAS7)

    The UAS combines daily wheal numbers (0 = none, 1 = < 20 wheals/24 h, 2 = 20-50 wheals/24 h, and 3= > 50 wheals/24 h or large confluent areas of wheals), and pruritus intensity (0 = none, 1 = present but not annoying or troublesome, 2 = troublesome but does not interfere with normal daily activity or sleep, and 3 = severe pruritus, which is sufficiently troublesome to interfere with normal daily activity or sleep). The score ranges from 0 to 42 weekly. The highest score, the more severe of urticaria activity.

    Measured: 6 weeks and 16 weeks

  2. Change of Urticaria Control Test (UCT)

    It collects retrospective information about the symptoms and quality of life impairment over the past 4 weeks. The lowest UCT score possible is 0 (no control) and the highest score possible is 16 (complete control). A score ≥12 indicates well-controlled urticaria, while a score of ≤11 points towards poor disease control.

    Measured: 6 weeks, 12 weeks and 16 weeks

  3. Change of Visual Analog Scale of Itch Severity (VAS)

    The VAS is a scale consisting of a 10 cm long line for measuring itch intensity and it has high reliability and concurrent validity. The highest score, the more itchiness.

    Measured: 6 weeks, 12 weeks and 16 weeks

  4. Change of Urticaria Quality of Life Questionnaire (CU-Q2oL)

    CU-Q2oL is a disease-specific questionnaire to measure the impact of disease on subjects' health-related quality of life in the last 2 weeks. The highest score, the poor quality of life.

    Measured: 6 weeks, 12 weeks and 16 weeks

  5. Change of Angioedema Activity Score (AAS)

    AAS is to assess disease activity in subjects with recurrent angioedema. The score ranges from 0 to 10 daily. The highest score, the more severe of the edema.

    Measured: 6 weeks, 12 weeks and 16 weeks

  6. Change of Immunoglobulin E (IgE) test

    To measure the change of IgE level between baseline and week 12

    Measured: 12 weeks

  7. Change of microbiota test

    To compare the presence and the relative amounts of some members of gut microbiota among patients with CU between baseline and week 12.

    Measured: 12 weeks

  8. The use of concomitant drugs

    The dose of using the standard therapy of the antihistamines, Bilastine during study period will be compared between each study follow up visit throughout the study

    Measured: Baseline, 6 weeks, 12 weeks and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2021
  2. Study start15 Aug 2021
  3. Primary completion7 Apr 2023
  4. Study completion7 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967092
Sponsor's protocol ID
C.Urticaria Study
Status last verified
Jul 2026
First submitted
14 Jul 2021
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hung HY, Song T, Loo SKF, Chan KL, Ching JYL, Sum CH, Lo LCW, Chia SCP, Ho RTM, Cheong PK, Siu THC, Leung KC, Lin ZX. Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study. Chin Med. 2022 Jul 22;17(1):87. doi: 10.1186/s13020-022-00642-3.

    PubMed 35869554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modified Xiao-Feng Powder + Antiallergics in people with Chronic Urticaria, run by Prof. Lin Zhixiu at 1 site in Hong Kong.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jul 2026. 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 Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Urticaria Activity Score (UAS7) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967092, which also lists 1 linked publication.

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 27 Jul 2026.

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