Modified Xiao-Feng Powder for Chronic Urticaria

December 1, 2021 updated by: Prof. Lin Zhixiu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Modified Xiao-Feng Powder
Modified Xiao-Feng Powder granules will be taken twice daily for 12 weeks
Drug: Modified Xiao-Feng Powder + Antiallergics
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_COMPARATOR: Placebo
Placebo granules will be taken twice daily for 12 weeks
Other: Placebo + Antiallergics
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Urticaria Activity Score (UAS7)
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Urticaria Activity Score (UAS7)
Time Frame: 6 weeks and 16 weeks
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.
6 weeks and 16 weeks
Change of Urticaria Control Test (UCT)
Time Frame: 6 weeks, 12 weeks and 16 weeks
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.
6 weeks, 12 weeks and 16 weeks
Change of Visual Analog Scale of Itch Severity (VAS)
Time Frame: 6 weeks, 12 weeks and 16 weeks
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.
6 weeks, 12 weeks and 16 weeks
Change of Urticaria Quality of Life Questionnaire (CU-Q2oL)
Time Frame: 6 weeks, 12 weeks and 16 weeks
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.
6 weeks, 12 weeks and 16 weeks
Change of Angioedema Activity Score (AAS)
Time Frame: 6 weeks, 12 weeks and 16 weeks
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.
6 weeks, 12 weeks and 16 weeks
Change of Immunoglobulin E (IgE) test
Time Frame: 12 weeks
To measure the change of IgE level between baseline and week 12
12 weeks
Change of microbiota test
Time Frame: 12 weeks
To compare the presence and the relative amounts of some members of gut microbiota among patients with CU between baseline and week 12.
12 weeks
The use of concomitant drugs
Time Frame: Baseline, 6 weeks, 12 weeks and 16 weeks
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
Baseline, 6 weeks, 12 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Lin Zhixiu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2021

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (ACTUAL)

July 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.Urticaria Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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