[Translation] A randomized, double-blind, multicenter phase IIa clinical trial on the safety and efficacy of Fufang Changtai Granules in the treatment of ulcerative colitis

初步探索复方肠泰颗粒治疗溃疡性结肠炎（湿热内蕴证）的有效性和安全性，为下一步临床试验提供设计依据。

[Translation]

To preliminarily explore the effectiveness and safety of Compound Changtai Granules in the treatment of ulcerative colitis (endogenous damp-heat syndrome) and provide a design basis for the next clinical trial.

Start Date-

Sponsor / Collaborator

The Second Military Medical University

100 Clinical Results associated with Compound Changtai Granules

100 Translational Medicine associated with Compound Changtai Granules

100 Patents (Medical) associated with Compound Changtai Granules

Literatures (Medical) associated with Compound Changtai Granules

01 Jan 2008·Journal of EthnopharmacologyQ2 · MEDICINE

Changtai granule, a traditional Chinese drug, protects hapten-induced colitis by attenuating inflammatory and immune dysfunctions

Q2 · MEDICINE

Article

Author: Yong-Bin Cao ; Yan Wang ; Yuan-Ying Jiang ; Ying-Ying Cao ; Bin-Guo Liu ; Ping-Hui Gao ; Shang-Hong Chen ; Xin-Ming Jia

The study was aimed to investigate the effects and mechanism of action of Changtai granule (CT), a traditional compound Chinese medicinal formula, in rodent 2,4,6-trinitrobenzene sulfonic acid (TNBS) colitis. Rats with TNBS/ethanol-induced colitis were used. The colonic wet weight, myeloperoxidase (MPO) activity, macroscopic and histological colon injury was observed. Inflammation cytokines were determined by ELISA methods and semi-quantitative RT-PCR. When dosed orally once daily, CT markedly attenuated TNBS-induced colitis. CT significantly attenuated colonic wet weight, macroscopic and histological colon injury. CT decreased mucosal mRNA levels for several inflammatory mediators: inducible nitric oxide synthase, cyclooxygenase 2, and macrophage inflammatory protein 2. CT also decreased mucosal mRNA and protein levels of T effectors cytokines: tumor necrosis factor-alpha (TNF-alpha), interleukin-2 (IL-2) and interferon-gamma (IFN-gamma). Systemic levels of these cytokines were also dramatically attenuated. CD3/CD28-mediated costimulation of T helper 1 effector cytokines release in lamina propria mononuclear cells (LPMC) was markedly inhibited by CT ex vivo and in vitro. Also CT prevented cytokines production by nuclear factor-kappaB (NF-kappaB). The potential anti-inflammatory and immunomodulatory effect of CT in TNBS colitis suggests that CT may be an effective treatment approach for inflammatory bowel disease.

01 Jan 2005·World Journal of GastroenterologyQ3 · MEDICINE

Effects of Changtai granules, a traditional compound Chinese medicine, on chronic trinitrobenzene sulfonic acid-induced colitis in rats

Q3 · MEDICINE

Article

Author: Cao, Yong-Bing ; Cheng, Ming-He ; Wang, Yan ; Jiang, Yuan-Ying ; Xu, Zheng ; Zhang, Jun-Dong ; Yan, Lan ; Jia, Xin-Ming ; Wang, De-Jun ; Diao, Ya-Ying ; Gao, Ping-Hui

AIMTo study the effects of Changtai granules (CTG), a traditional compound Chinese medicine, on chronic trinitrobenzene sulfonic acid-induced colitis in rats.METHODSHealthy adult Sprague-Dawley (SD) rats of both sexes, weighing 250-300 g, were employed in the present study. The rat colitis models were induced by 2,4,6-trinitrobenzene sulfonic acid (TNBS) enemas at a concentration of 100 mg/kg in 50% ethanol. The experimental animals were randomly divided into dexamethasone (DX) treatment, CTG treatment, and model control groups, which were intracolicly treated daily with DX (0.2 mg/kg), CTG at doses of 2.9, 5.7 and 11.4 g crude drug/kg, and the equal amount of saline respectively from 6 h following induction of the colitis in rats inflicted with TNBS to the end of study. A normal control group of rats treated without TNBS but saline enema was also included in the study. After 3 wk of treatment, the animals were assessed for colonal inflammatory and ulcerative responses with respect to mortality, frequency of diarrhea, histology and myeloperoxidase activity (MPO).RESULTSThe therapeutic effect of CTG on ulcerative colitis (UC) was better than DX. CTG effectively inhibited the activity of granulocytes, macrophages and monocytes in a dose-dependent manner. Also it reduced MPO and formation of inflammation in colonic mucosal tissue. Furthermore, administration of CTG significantly prevented body mass loss and death, and decreased frequency of diarrhea in UC rats, when compared with the model control group rats.CONCLUSIONCTG would prove to be an ideal drug for chronic UC, and is warranted to be studied further.

100 Deals associated with Compound Changtai Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	CN	The Second Military Medical University	28 Jul 2014

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