[Translation] A randomized, double-blind, placebo-controlled, multicenter, superiority clinical trial on the efficacy and safety of Jinchan Zhiyang Capsule in subacute eczema (endogenous damp-heat syndrome)

评价金蝉止痒胶囊用于亚急性湿疹（湿热内蕴证）的有效性及安全性，为其新增亚急性湿疹的适应症提供依据。

[Translation]

To evaluate the efficacy and safety of Jinchan Zhiyang Capsule in subacute eczema (endogenous damp-heat syndrome) and provide a basis for its new indication of subacute eczema.

Start Date28 Aug 2020

Sponsor / Collaborator

Chongqing Hilan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Jinchan Zhiyang Capsule

100 Translational Medicine associated with Jinchan Zhiyang Capsule

100 Patents (Medical) associated with Jinchan Zhiyang Capsule

Literatures (Medical) associated with Jinchan Zhiyang Capsule

01 Jul 2024·Heliyon

Effect of a topical traditional Chinese herbal medicine on skin microbiota in mouse model of atopic dermatitis

Article

Author: Yang, Zhibo ; Zhou, Yi ; Zeng, Bijun ; An, Lili ; Liu, Xuewei ; Cui, Gutao

This study aims to explore the impact of the herbal ointment Chushi Zhiyang Ruangao (CSZYRG) on the skin's microecological environment in a mouse model of atopic dermatitis (AD) and to understand the underlying mechanisms involved. The AD model was established in C57 mice using calpolitol (a hypocalcemic analog of vitamin D3; MC903). Medication-free matrix ointment, CSZYRG, and mometasone furoate cream (positive control group) were applied to the injured areas. The skin lesions of AD model mice were photographed. Skin lesions were applied for the hematoxylin and eosin (H&E) staining to observe any pathological changes. Serum immunoglobulin IgE was detected by enzyme-linked immunosorbent assay (ELISA). The changes in the expression of inflammation-related factors TNF-α, IL-1β, and IL-6 in mice were detected using ELISA and qRT-PCR. Skin microflora samples were taken for 16S rDNA sequencing and analyzed for changes in the skin flora diversity, abundance, and dominant flora in mice. It was concluded that CSZYRG effectively alleviates skin lesions, serum IgE, and levels of TNF-α, IL-1β, and IL-6 in AD model mice. However, CSZYRG did not affect the skin microbial diversity of AD model mice but could exert an effect on the skin microbial community in AD mice and the relative abundance of the dominant microflora. CSZYRG may play a therapeutic role in AD by affecting the skin microbial community and relative abundance of dominant microflora in AD mice.

17 Sep 2022·Evidence-Based Complementary and Alternative Medicine

A Meta-Analysis of Randomized Clinical Trials of Runzao Zhiyang Capsule in Chronic Urticaria

Article

Author: Xiao, Xianjun ; Zhang, Xueer ; Ye, Shengzhen ; Chen, Mingling ; Ling, Guihua ; Huang, Dan

Chinese herbal medicine has many advantages in the treatment of chronic urticaria (CU). Herein, we evaluated the efficacy and safety of the Runzao Zhiyang (RZZY, Chinese patent herbal medicine capsule) capsule for CU through a meta-analysis of randomized clinical trials (RCTs). This meta-analysis included 17 RCTs involving 1,760 patients. RZZY capsule combined with conventional drugs showed a better clinical total effective rate (risk ratio (RR) = 1.20, 95% confidence interval (CI) (1.15, 1.24),

P < 0.00001

), significantly reduced the adverse reaction rate [RR = 0.68, 95% CI (0.50, 0.92),

P = 0.01

] and recurrence rate [RR = 0.29, 95% CI (0.18, 0.46),

P < 0.00001

], and improved the life quality of patients (mean difference (MD) = −2.95, 95% CI (−4.32, −1.57),

P = 0.0001

). Meanwhile, the serum Interleukin-4 (IL-4) (MD = −13.83, 95% CI (−23.45, −4.20),

P = 0.005

) and immunoglobulin E (IgE) (MD = −22.99, 95% CI (−31.48, −14.50),

P < 0.00001

) of patients in the intervention group decreased more significantly. In all, the RZZY capsule has potential therapeutic advantages and is relatively safe for CU. However, we are cautious about the conclusion, which needs to be further confirmed by more large samples, multicenter, and high-quality research in the later stage.

01 Jan 2022·Integrative Cancer Therapies

Topical Zhiyang Pingfu Liquid for Moderate to Severe Skin Rash Associated With EGFRIs: A double-blinded randomized controlled trial

Article

Author: Tan, Kexin ; Zhang, Jingyi ; Li, Jia ; Cui, Huijuan ; Zhang, Xu ; Lu, Xingyu

Background: Skin rash is the most common adverse effect associated with epidermal growth factor receptor inhibitors (EGFRIs). The study has observed the efficacy and safety of Zhiyang Pingfu Liquid in the treatment of EGFRIs-related moderate and severe rash. Methods: Patients suffering from EGFRIs-related moderate to severe rash were enrolled and then randomly divided into the treatment group and the control group, receiving Zhiyang Pingfu Liquid and placebo liquid respectively combined with minocycline and methylprednisolone recommended by guideline for 14 days. Changes in rash grades were observed, as well as the dosage of minocycline. Blood routine examination and liver and kidney function were evaluated to observe the safety of Zhiyang Pingfu Liquid. The total response of rash included complete response (CR) and partial response (PR). And the effective rate of rash was the percentage of CR and PR in the total cases. Results: A total of 54 out of 58 patients finished the study with 27 patients in each group. The effective rates of rash among the treatment group and the control group were 81.48% and 55.56% after 14 days treatment ( P = .040). The treatment group had a lower dosage of minocycline compared with the control group. The median total dose of oral minocycline administration was 1000 mg in the treatment group and 1400 mg in the control group. Conclusion: Zhiyang Pingfu Liquid can effectively improve the moderate and severe EGFRIs-induced rash, and reduce the use of minocycline, as well as the side reactions brought by minocycline. However, larger randomized controlled trials are needed to verify these findings. Clinical Trial Registration: The trial was registered on the Chinese Clinical Trial Registry, the registration number is ChiCTR1800017053.

100 Deals associated with Jinchan Zhiyang Capsule

R&D Status

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Indication	Country/Location	Organization	Date
Dermatitis	CN	Chongqing Hilan Pharmaceutical Co., Ltd.	22 Mar 2019
Urticaria	CN	Chongqing Hilan Pharmaceutical Co., Ltd.	22 Mar 2019

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