[Translation] A randomized, double-blind, double-dummy, dose-finding, active drug parallel-controlled, multicenter phase II clinical trial on the efficacy and safety of Qingchang Wenzhong Tablets in the treatment of moderately active ulcerative colitis (cold-heat mixed syndrome, damp-heat stasis syndrome).

采用随机、双盲双模拟、剂量探索、阳性药平行对照、多中心临床试验设计，初步评价清肠温中片治疗中度活动期溃疡性结肠炎（寒热错杂、湿热瘀阻证）的有效性和安全性，探索清肠温中片对溃疡性结肠炎患者诱导缓解的作用，并为确证性临床试验提供数据支持。

[Translation]

A randomized, double-blind, double-simulation, dose-finding, positive drug parallel-controlled, multicenter clinical trial design was used to preliminarily evaluate the efficacy and safety of Qingchang Wenzhong Tablets in the treatment of moderately active ulcerative colitis (mixed cold and heat, damp-heat and blood stasis syndrome), explore the effect of Qingchang Wenzhong Tablets in inducing remission in patients with ulcerative colitis, and provide data support for confirmatory clinical trials.

Start Date17 Nov 2022

Sponsor / Collaborator

Yangzijiang Pharmaceutical Group Jiangsu Longfengtang Traditional Chinese Medicine Co., Ltd.

100 Clinical Results associated with Qingchang Wenzhong

100 Translational Medicine associated with Qingchang Wenzhong

100 Patents (Medical) associated with Qingchang Wenzhong

Literatures (Medical) associated with Qingchang Wenzhong

01 Feb 2024·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Qingchang suppositry induced remission in patients with mild-to-moderate ulcerative proctitis: a multicenter, prospective, randomized, parallel-controlled clinical trial.

Article

Author: Hongzhu, Wen ; Xiaoling, Dai ; Xiaoyan, Fei ; Yi, Ren ; Bei, Shi ; Jiang, Lin ; Anming, Zhang ; Hui, Lin

OBJECTIVETo evaluate the efficacy and safety of Qingchang suppository (, QCS), a preparation of Chinese herbal medicine, in the induction of remission in patients with mild-to-moderate ulcerative proctitis (UP).METHODSWe performed a multicenter, prospective, randomized, parallel-controlled trial to evaluate the efficacy of QCS induction therapy in 140 adult patients with mild-to-moderate UP and TCM syndrome of dampness-heat in large intestine. The patients were randomized to receive QCS (study group) or Salicylazosulfapyridine (SASP) suppository (control group) one piece each time, twice a day, per anum for 12 weeks. Mayo score and main symptoms score were evaluated at weeks 0, 2, 4, 8 and 12, rectosigmoidscopy was taken at weeks 0, 4, 8 and 12, Geboes score, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and safety indexes were assessed at weeks 0 and 12. The primary efficacy endpoint is clinical remission rate, the secondary efficacy endpoints are clinical response rate, mucosa healing rate, Geboes score, the remission rates of the main symptoms, the median day to the remission of the symptom, etc. RESULTS: There were no statistical difference in the clinical remission rates, the clinical response rates, the mucosa healing rates, Geboes score, ESR and CRP between the two groups. The remission rates of tenesmus and anal burning sensation of the study group were significantly higher than those of the control group (76.5% vs 25.0%, P = 0.009; 74.51% vs 29.63%, P = 0.003). The median day to the remission of purulent bloody stool of the study group was significantly less than that of control group [11 (1, 64) vs 19 (2, 67), P = 0.007]. The patients receiving QCS had a significantly higher mucosa healing rate at week 4 than the patients receiving SASP suppository (71.42% vs 52.85%, P = 0.023). No adverse event occurred in the study group while the adverse events incidence of the control group was 5.7% (P = 0.049).CONCLUSIONSQCS could induce the remission of UP as effectively and safely as SASP suppository, and was superior to SASP suppository in relieving the symptoms of tenesmus, anal burning sensation and purulent bloody stool and the time to reach mucosa healing.

01 Jan 2023·Frontiers in pharmacology

Mechanism of Qingchang Suppository on repairing the intestinal mucosal barrier in ulcerative colitis.

Review

Author: Lin, Jiang ; Liu, Haoyue ; Yuan, Jianye ; Shan, Jingyi ; Liu, Suxian

Ulcerative colitis (UC) is a refractory inflammatory bowel disease, and the outcomes of conventional therapies of UC, including 5-aminosalicylic acid, glucocorticoids, immunosuppressants, and biological agents, are not satisfied with patients and physicians with regard to adverse reactions and financial burden. The abnormality of the intestinal mucosal barrier in the pathogenesis of UC was verified. Qingchang Suppository (QCS) is an herbal preparation and is effective in treating ulcerative proctitis. The mechanism of QCS and its active ingredients have not been concluded especially in mucosal healing. This review elucidated the potential mechanism of QCS from the intestinal mucosal barrier perspective to help exploring future QCS research directions.

25 Aug 2022·BioMed Research International

Qingchang Wenzhong Decoction Alleviates DSS-Induced Inflammatory Bowel Disease by Inhibiting M1 Macrophage Polarization In Vitro and In Vivo

Article

Author: Shi, Rui ; Sun, Zhongmei ; Li, Yalan ; Li, Junxiang ; Ding, Panghua ; Shi, Lei ; Lu, Qiongqiong ; Tan, Xiang ; Mao, Tangyou ; Yang, Xiaojun ; Jiang, Hui ; Dong, Junying

Background. An imbalance of macrophage M1/M2 polarization significantly influences the pathogenesis of inflammatory bowel disease. Qingchang Wenzhong decoction (QCWZD) has a proven therapeutic effect on patients with inflammatory bowel disease (IBD) and can significantly inhibit the inflammatory response in mice with colitis. However, its effect on macrophages during IBD treatment remains nebulous. Aim of the Study. Explore the mechanism underlying QCWZD effects in a dextran sulfate sodium (DSS)-induced colitis mouse model in vivo and RAW264.7 cell in vitro by observing macrophage polarization dynamics. Methods. The main active components of QCWZD were determined using high-performance liquid chromatography. Surface marker expression on M1-type macrophages was analyzed using flow cytometry and immunofluorescence. The effect on inducible nitric oxide synthase (iNOS), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) released by M1 type macrophages was determined using ELSA and RT-PCR. The expression of key proteins in the JAK2/STAT3 signaling pathway was analyzed using western blotting. QCWZD cytotoxicity in macrophages was measured using CCK8 and Annexin V-FITC/PI assays. Results. The main active components of QCWZD were berberine chloride, coptisine chloride, epiberberine chloride, gallic acid, ginsenoside Rg1, ginsenoside Rb1, indigo, indirubin, notoginsenoside R1, palmatine chloride, and 6-curcumin. QCWZD markedly alleviated DSS-induced colitis in mice, as revealed by the rescued weight loss and disease activity index, attenuated the colonic shortening and mucosal injury associated with the inhibition of M1 macrophage polarization and expression of related cytokines, such as IL-6 and TNF-α, in vivo and in vitro. Furthermore, QCWZD decreased the iNOS, JAK2, and STAT3 levels in vivo and in vitro, regulating the JAK2/STAT3 signaling pathway. Conclusion. QCWZD administration improves intestinal inflammation by inhibiting M1 macrophage polarization. The JAK2/STAT3 signaling pathway may mediate the effects of QCWZD on M1 macrophage polarization in colitis treatment. This study presents a novel macrophage-mediated therapeutic strategy for the treatment of IBD.

100 Deals associated with Qingchang Wenzhong

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	CN	Yangzijiang Pharmaceutical Group Jiangsu Longfengtang Traditional Chinese Medicine Co., Ltd.	17 Nov 2022

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