scholarly journals Chinese Herbal Formula Huoxiang Zhengqi for Dampness Pattern in Atopic Dermatitis and Diarrhea-Predominant Irritable Bowel Syndrome: Rationale and Design of a Master Protocol

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Qian Huang ◽  
Xiaohui Guo ◽  
Meiling Xuan ◽  
Wenwei Ouyang ◽  
Zehuai Wen

Introduction. Atopic dermatitis (AD) and diarrhea-predominant irritable bowel syndrome (IBS-D) are two recurrent diseases with limited effective treatments. In Chinese Medicine (CM) theory, they may share dampness pattern as the same dominant pathogenesis at a certain stage and, thus, can be treated with the same method. While Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been reported as an effective dampness-resolving therapy for both AD and IBS-D, further high-quality clinical studies are still needed. In addition, HXZQ lacks accurate clinical positioning based on CM patterns. Therefore, we utilize a master protocol design to evaluate HXZQ for dampness pattern simultaneously in AD and IBS-D, with the aim of identifying the pattern-defined population of HXZQ. Methods and Analysis. This master protocol design includes two randomized controlled trials (RCTs) and a real-world observational study. Based on two registry cohorts of AD and IBS-D, patients with dampness pattern will be enrolled in the RCTs to receive either HXZQ oral liquid or a placebo for 4 weeks and then will be followed up for another 4 weeks, while patients with nondampness pattern will constitute the observational study and experience a 12-week follow-up. A total of 678 AD patients and 322 IBS-D patients will be recruited from 14 hospitals in China over a 3-year period. The eczema area and severity index (EASI) and the proportion of responders for adequate relief (AR) are the primary outcomes in AD and IBS-D, respectively. Analysis will be undertaken separately in each substudy, and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of HXZQ. Discussion. This study will provide high-quality efficacy evidence of HXZQ for AD and IBS-D patients and give an example of postmarketing evaluation for CM products under the pattern dominating different disease research model. The study is registered with ChiCTR1900026700 and ChiCTR1900026837.

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Hong-Yan Qin ◽  
Hai-Tao Xiao ◽  
Fung-Ping Leung ◽  
Zhi-Jun Yang ◽  
Justin C. Y. Wu ◽  
...  

The present study aimed to investigate the analgesic effect of JCM-16021, a revised traditional Chinese herbal formula, on postinflammatory irritable bowel syndrome (PI-IBS) in rats. The trinitrobenzene sulfonic (TNBS) acid-induced PI-IBS model rats were orally administrated with different doses of JCM-16021 (1.2, 2.4, and 4.8 g/kg/d) for 14 consecutive days. The results showed that JCM-16021 treatment dose-dependently attenuated visceral hyperalgesia in PI-IBS rats. Further, the colonic enterochromaffin (EC) cell number, serotonin (5-HT) content, tryptophan hydroxylase expression, and mechanical-stimuli-induced 5-HT release were significantly ameliorated. Moreover, the decreased levels of mucosal cytokines in PI-IBS, especially the helper T-cell type 1- (Th1-) related cytokine TNF-α, were also elevated after JCM-16021 treatment. These data demonstrate that the analgesic effect of JCM-16021 on TNBS-induced PI-IBS rats may be medicated via reducing colonic EC cell hyperplasia and 5-HT availability.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaohui Guo ◽  
Meiling Xuan ◽  
Huan Zheng ◽  
Shumin Qin ◽  
Haomeng Wu ◽  
...  

Abstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. Methods This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. Discussion This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. Trial registration The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837. Registered on 24 October 2019.


2006 ◽  
Vol 12 (4) ◽  
pp. 401-407 ◽  
Author(s):  
Zhaoxiang Bian ◽  
Taixiang Wu ◽  
Liang Liu ◽  
Jiangxia Miao ◽  
Honfat Wong ◽  
...  

Medicine ◽  
2021 ◽  
Vol 100 (10) ◽  
pp. e24019
Author(s):  
JiHo Lee ◽  
Won-Suk Sung ◽  
Eun-Jung Kim ◽  
Young Woo Kim

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Fenggen Yan ◽  
Jing Zhang ◽  
Xiong Li ◽  
Xiumei Mo ◽  
Junfeng Liu ◽  
...  

Atopic dermatitis (AD), also known as atopic eczema, is a chronic pruritic inflammatory skin disease. The available systemic therapies for atopic dermatitis are inadequate. Objective. This study aimed to evaluate the effects of the Chinese herbal formula Pei Tu Qing Xin (PTQX) on dermatitis severity and ear swelling, immunomodulation, and the infiltration of mast cells in a mouse model of 1-chloro-2,4-dinitrobenzene- (DNCB-) induced AD. Methods. AD-like symptoms were induced by DNCB in NC/Nga mice. Skin lesions, dermatitis, ear swelling, and scratching behaviour were evaluated. Changes in the T-helper type 1 (Th1), Th2, Th17, and regulatory T (Treg) subtypes and immunoregulation in the spleen and lymph nodes were detected by flow cytometry. Results. Histopathological and immunohistochemical analyses demonstrated that PTQX decreased the DNCB-mediated induction of mast cells and infiltration of inflammatory cells in the ear and dorsal skin. PTQX also reduced the DNCB-induced increase in the serum immunoglobulin E level, pruritus, and dermatitis (red, flaky areas) on the dorsal skin. Furthermore, PTQX regulated the balance between the populations of Th1, Th2, Th17, and Treg cells (particularly the latter two) in the lymph nodes. Conclusions. Our results suggest that the Chinese herbal formula PTQX can alleviate symptoms of AD, such as epithelial damage, redness, swelling, and pruritus, and potentially be used to treat this condition.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Meiling Xuan ◽  
Xiaohui Guo ◽  
Hongyi Li ◽  
Ting Xie ◽  
Xiumei Mo ◽  
...  

Abstract Background Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-level evidence for its effect on AD/eczema. The aim of this trial is to examine the efficacy and safety of HXZQ treating AD/eczema patients. Methods This is a double-blind, multi-center, randomized controlled trial comparing HXZQ to a placebo. It will consist of 4 weeks’ treatment and 4 weeks of follow-up. A total of 218 participants will be randomly allocated into two groups—an HXZQ group and a placebo group, from 7 hospitals in China. Patients diagnosed with AD will be enrolled if they are in accordance with CM dampness pattern, have body surface area (BSA) of 1–10%, have investigator’s global assessment (IGA) of 1–3, have age between 18 and 70 years, and provide signed informed consent. The Eczema Area and Severity Index (EASI) is the primary outcome. The secondary outcomes are the numerical itch rating scale, IGA, BSA, Skindex-29, and EQ-5D-5L score, from baseline to the end of the treatment. Analysis will be on intention-to-treat and per-protocol subject analysis principles. Discussion The goal of this trial is to evaluate the efficacy and availability of HXZQ oral liquid in treating AD/eczema in terms of symptoms and eczematous lesions. It will also address whether it has positive effect on QoL. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx): Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a double-blinded randomized controlled trial, ChiCTR1900026700. Registered on 19 October 2019.


2021 ◽  
pp. 114021
Author(s):  
Lan Wang ◽  
Yan-Fang Xian ◽  
Zhen Hu ◽  
Steven King Fan Loo ◽  
Siu Po Ip ◽  
...  

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