PMID- 35869554
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220729
IS  - 1749-8546 (Print)
IS  - 1749-8546 (Electronic)
IS  - 1749-8546 (Linking)
VI  - 17
IP  - 1
DP  - 2022 Jul 22
TI  - Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic 
      urticaria: protocol of a randomized double-blind placebo-controlled study.
PG  - 87
LID - 10.1186/s13020-022-00642-3 [doi]
LID - 87
AB  - BACKGROUND: Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in 
      Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous 
      lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing 
      Powder), is reported to be one of the most frequently used Chinese herbal 
      formulae for CU. In this study, we aim to investigate the effectiveness and 
      safety of modified Xiao-Feng Powder (mXFP) for the treatment of CU. METHODS: In 
      this randomised double-blind placebo-controlled clinical trial, 58 subjects 
      identified as having mild to severe urticaria (Urticaria activity score greater 
      than 10) will be recruited and randomised into two groups to receive 
      antihistamine Bilastine with either mXFP or placebo for 12 weeks, followed by 
      post treatment visits at week 16. The primary outcome measure is the change of 
      weekly urticaria activity score (UAS7) at week 12. Secondary outcome measures 
      include the Urticaria Control Test (UCT), Visual Analog Scale of Itch Severity 
      (VAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Angioedema 
      Activity Score (AAS), immunoglobulin E (IgE) test, gut microbiota test and use of 
      antihistamines during study period. The trial will be conducted at three Chinese 
      medicine clinics in Hong Kong. EXPECTED OUTCOMES: The results of this study will 
      establish robust clinical evidence about the efficacy and safety of mXFP in the 
      treatment of CU. A specific feature of this trial is that it is a integrative 
      medicine trial with subjects being allowed to take the Western and Chinese 
      medicine together for the treatment. Trial registration This is registered on 
      ClinicalTrials.gov, ID: NCT04967092. Register date: July 19, 2021. 
      https://clinicaltrials.gov/ct2/show/NCT04967092 .
CI  - (c) 2022. The Author(s).
FAU - Hung, Hing Yu
AU  - Hung HY
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
AD  - School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong 
      Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Song, Tianhe
AU  - Song T
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China. thsongm@gmail.com.
FAU - Loo, Steven King Fan
AU  - Loo SKF
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Chan, Kam Leung
AU  - Chan KL
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
AD  - School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong 
      Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Ching, Jessica Yuet Ling
AU  - Ching JYL
AD  - Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Sum, Chi Him
AU  - Sum CH
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Lo, Louis Cho Wing
AU  - Lo LCW
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Chia, Sarah Chon Pin
AU  - Chia SCP
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Ho, Ray Tin Muk
AU  - Ho RTM
AD  - School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong 
      Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Cheong, Pui Kuan
AU  - Cheong PK
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Siu, Tony Hon Chung
AU  - Siu THC
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Leung, Ka Chun
AU  - Leung KC
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
FAU - Lin, Zhi-Xiu
AU  - Lin ZX
AD  - Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese 
      University of Hong Kong, Shatin, N.T., Hong Kong SAR, China. linzx@cuhk.edu.hk.
AD  - School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong 
      Kong, Shatin, N.T., Hong Kong SAR, China. linzx@cuhk.edu.hk.
LA  - eng
SI  - ClinicalTrials.gov/NCT04967092
PT  - Journal Article
DEP - 20220722
PL  - England
TA  - Chin Med
JT  - Chinese medicine
JID - 101265109
PMC - PMC9308295
OTO - NOTNLM
OT  - Chinese medicine
OT  - Urticaria
OT  - Xiao-Feng Powder
COIS- None of the authors have any competing interests to declare.
EDAT- 2022/07/23 06:00
MHDA- 2022/07/23 06:01
PMCR- 2022/07/22
CRDT- 2022/07/22 23:48
PHST- 2022/04/07 00:00 [received]
PHST- 2022/07/09 00:00 [accepted]
PHST- 2022/07/22 23:48 [entrez]
PHST- 2022/07/23 06:00 [pubmed]
PHST- 2022/07/23 06:01 [medline]
PHST- 2022/07/22 00:00 [pmc-release]
AID - 10.1186/s13020-022-00642-3 [pii]
AID - 642 [pii]
AID - 10.1186/s13020-022-00642-3 [doi]
PST - epublish
SO  - Chin Med. 2022 Jul 22;17(1):87. doi: 10.1186/s13020-022-00642-3.