Modified Xiao-Feng Powder for Chronic Urticaria

NCT04967092 | Unknown Phase 2 DMC

• 1 other identifier: C.Urticaria Study
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Urticaria

Keywords

Chronic Urticaria; Chinese Medicines

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (8)

• Change of Urticaria Activity Score (UAS7)

  6 weeks and 16 weeks

• Change of Urticaria Control Test (UCT)

  6 weeks, 12 weeks and 16 weeks

• Change of Visual Analog Scale of Itch Severity (VAS)

  6 weeks, 12 weeks and 16 weeks

• Change of Urticaria Quality of Life Questionnaire (CU-Q2oL)

  6 weeks, 12 weeks and 16 weeks

• Change of Angioedema Activity Score (AAS)

  6 weeks, 12 weeks and 16 weeks

Study Arms (2)

Modified Xiao-Feng Powder

ACTIVE COMPARATOR

Modified Xiao-Feng Powder granules will be taken twice daily for 12 weeks

Drug: Modified Xiao-Feng Powder + Antiallergics

Placebo

PLACEBO COMPARATOR

Placebo granules will be taken twice daily for 12 weeks

Other: Placebo + Antiallergics

Interventions

Modified Xiao-Feng Powder + Antiallergics DRUG

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.

Modified Xiao-Feng Powder

Placebo + Antiallergics OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Lin Zhixiu: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 35869554 DERIVED

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Anti-Allergic Agents

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zhixiu Lin, PhD

  Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu Lin, PhD

CONTACT

35053476; linzx@cuhk.edu.hk

Yuet Ling, Jessica Ching, MPH

CONTACT

35053524; jessicaching@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 19, 2021
• Study Start: August 15, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)