Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial
Joint Authors
Xu, Rong
Li, Bin
Li, Xin
Li, Su
Zhang, Cang
Zhang, Hong-Ya
Zhou, Meng
Wang, Si-Nong
Zhou, Dong-Mei
Ji, Yun-Run
Lv, Jing-Jing
Yin, Qing-Feng
Wang, Rui-Ping
Li, Wei
Liu, Yan-Ping
Wang, Jian-Feng
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-04-09
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Introduction.
The etiology and pathogenesis of psoriasis are complex.
Blood-heat syndrome is the core pathogenesis of psoriasis.
Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment.
Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis.
This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL).
This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis.
Methods and Analysis.
A five-center randomized double-blind placebo-controlled clinical design will be used in this study.
At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks).
The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up.
The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values.
The primary outcome measure will be the psoriasis lesion area severity index.
We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events.
This trial is registered with NCT03961230.
American Psychological Association (APA)
Li, Su& Zhang, Cang& Zhang, Hong-Ya& Zhou, Meng& Wang, Si-Nong& Xu, Rong…[et al.]. 2020. Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1158270
Modern Language Association (MLA)
Li, Su…[et al.]. Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1158270
American Medical Association (AMA)
Li, Su& Zhang, Cang& Zhang, Hong-Ya& Zhou, Meng& Wang, Si-Nong& Xu, Rong…[et al.]. Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1158270
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1158270