Back to resultsModified Xiao-Feng Powder for Chronic Urticaria
Primary Purpose
Chronic Urticaria
Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Modified Xiao-Feng Powder + Antiallergics
Placebo + Antiallergics
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Urticaria focused on measuring Chronic Urticaria, Chinese Medicines
Eligibility Criteria
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:
- 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.
- Know recent history (within previous 12 months) of drug addiction or alcohol abuse.
- Involved in other interventional clinical studies at the same time.
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Modified Xiao-Feng Powder
Placebo
Arm Description
Modified Xiao-Feng Powder granules will be taken twice daily for 12 weeks
Placebo granules will be taken twice daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Change of Immunoglobulin E (IgE) test
To measure the change of IgE level between baseline and week 12
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967092
Brief Title
Modified Xiao-Feng Powder for Chronic Urticaria
Official Title
Efficacy and Safety of Modified Xiao-Feng Powder in the Treatment of Chronic Urticaria - A Double-Blind Randomized Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Lin Zhixiu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
Chronic Urticaria, Chinese Medicines
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified Xiao-Feng Powder
Arm Type
Active Comparator
Arm Description
Modified Xiao-Feng Powder granules will be taken twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo granules will be taken twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Modified Xiao-Feng Powder + Antiallergics
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo + Antiallergics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Urticaria Activity Score (UAS7)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of Urticaria Activity Score (UAS7)
Description
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.
Time Frame
6 weeks and 16 weeks
Title
Change of Urticaria Control Test (UCT)
Description
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.
Time Frame
6 weeks, 12 weeks and 16 weeks
Title
Change of Visual Analog Scale of Itch Severity (VAS)
Description
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.
Time Frame
6 weeks, 12 weeks and 16 weeks
Title
Change of Urticaria Quality of Life Questionnaire (CU-Q2oL)
Description
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.
Time Frame
6 weeks, 12 weeks and 16 weeks
Title
Change of Angioedema Activity Score (AAS)
Description
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.
Time Frame
6 weeks, 12 weeks and 16 weeks
Title
Change of Immunoglobulin E (IgE) test
Description
To measure the change of IgE level between baseline and week 12
Time Frame
12 weeks
Title
Change of microbiota test
Description
To compare the presence and the relative amounts of some members of gut microbiota among patients with CU between baseline and week 12.
Time Frame
12 weeks
Title
The use of concomitant drugs
Description
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
Time Frame
Baseline, 6 weeks, 12 weeks and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Know recent history (within previous 12 months) of drug addiction or alcohol abuse.
Involved in other interventional clinical studies at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhixiu Lin, PhD
Phone
35053476
Email
linzx@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Yuet Ling, Jessica Ching, MPH
Phone
35053524
Email
jessicaching@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin, PhD
Organizational Affiliation
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-xiu Lin, PhD
Email
linzx@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35869554
Citation
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.
Results Reference
derived
Learn more about this trial
Modified Xiao-Feng Powder for Chronic Urticaria
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