Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
58 participants
INTERVENTIONAL
2021-08-15
2023-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Modified Xiao-Feng Powder
Modified Xiao-Feng Powder granules will be taken twice daily for 12 weeks
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
Placebo granules will be taken twice daily for 12 weeks
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.
Interventions
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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 + 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Prof. Lin Zhixiu
OTHER
Responsible Party
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Prof. Lin Zhixiu
Professor
Principal Investigators
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Zhixiu Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Zhi-xiu Lin, PhD
Role: primary
References
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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.
Other Identifiers
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C.Urticaria Study
Identifier Type: -
Identifier Source: org_study_id