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Ancient herb mix put to the test against stubborn hives

NCT ID NCT04967092

Disease control Sponsor: Prof. Lin Zhixiu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a modified version of the traditional Chinese herbal formula Xiao-Feng Powder can reduce itching and wheals in people with chronic urticaria (hives lasting more than 6 weeks). About 58 adults will receive either the herbal granules or a placebo twice daily for 12 weeks, along with the antihistamine bilastine. The study measures changes in a daily hive-and-itch score to see if adding the herbal formula improves symptom control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a modified Chinese herbal formula called Xiao-Feng Powder, taken as granules twice daily for 12 weeks, plus the antihistamine bilastine
What this could lead to
If effective, this herbal formula could offer a new option for managing chronic hives with fewer side effects than standard treatments.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. Herbal products can vary in quality and may cause allergic reactions or interact with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

58 people

The number who actually took part.

Started

Aug 2021

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Both male and female; 2. Age from 18 to 65 years; 3. Documented history of CU for at least 6 weeks prior to entry in the study; 4. 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; 5. Symptom severity must be greater than 10 points (UAS7 score); 6. Able to complete questionnaires and take medications as scheduled; and 7. Agree to participate in the study and sign the informed consent. Exclusion Criteria: 1. Dual deficiency of Qi and blood according to Chinese medicine theory 2. Urticaria is induced by physical factors (e.g., cold urticaria, delayed pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema) only; 3. Known to have dermatological diseases with skin pruritus; 4. 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; 5. Known to use oral/injectable corticosteroids, leukotriene inhibitors, immunosuppressants or other Chinese herbal medicine within one month of enrollment; 6. Known to receive omalizumab, ligelizumab, or other experimental biologic for CU; 7. Documented pregnancy or planning to conceive, breast-feeding women; or 8. Operate heavy machinery or need to drive motor vehicles as an essential part of their profession. 9. Know recent history (within previous 12 months) of drug addiction or alcohol abuse. 10. Involved in other interventional clinical studies at the same time.

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Conditions

The condition(s) this trial relates to.

chronic urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic urticaria

Contacts and locations

Locations

  • The Chinese University of Hong Kong

    Shatin, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.