[Translation] A multicenter, randomized, double-blind, placebo-controlled phase Ⅱb clinical trial to evaluate the efficacy and safety of Changji'an capsule in the treatment of diarrhea-predominant irritable bowel syndrome (liver qi invading spleen syndrome)

1、以安慰剂为对照，初步评价肠激安胶囊用于腹泻型肠易激综合征（肝气乘脾证）患者的有效性； 2、观察肠激安胶囊临床应用的安全性。

[Translation]

1. Using placebo as control, preliminarily evaluate the effectiveness of Changji'an Capsules in patients with diarrhea-type irritable bowel syndrome (liver qi invading spleen syndrome); 2. Observe the safety of Changji'an Capsules in clinical application.

Start Date21 Feb 2023

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

CTR20180991 / CompletedPhase 2IIT

采用随机、双盲单模拟、安慰剂为平行对照的多中心临床试验设计，初步评价肠激安胶囊用于腹泻型肠易激综合征患者有效性及安全性的探索性试验

[Translation] A randomized, double-blind, single-dummy, placebo-controlled, multicenter clinical trial was conducted to preliminarily evaluate the efficacy and safety of Changji'an Capsules in patients with diarrhea-predominant irritable bowel syndrome.

初步评价肠激安胶囊用于腹泻型肠易激综合征（肝气乘脾证）患者的有效性及安全性。

[Translation]

To preliminarily evaluate the efficacy and safety of Changji'an Capsule in patients with diarrhea-predominant irritable bowel syndrome (liver qi invading spleen syndrome).

Start Date08 Oct 2018

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

CTR20160031 / SuspendedPhase 2IIT

肠激安胶囊治疗肠易激综合征腹泻型(肝郁脾虚证)的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial of Changji'an capsule in the treatment of irritable bowel syndrome with diarrhea (liver depression and spleen deficiency syndrome)

(1) 初步评价肠激安胶囊与安慰剂相比较治疗肠易激综合征腹泻型(肝郁脾虚证)的有效性； (2) 初步评价肠激安胶囊治疗肠易激综合征腹泻型(肝郁脾虚证)的安全性； (3) 探索肠激安胶囊治疗肠易激综合征腹泻型(肝郁脾虚证)的最佳剂量。

[Translation]

(1) To preliminarily evaluate the effectiveness of Changji'an Capsules in treating irritable bowel syndrome (diarrhea type) (liver depression and spleen deficiency syndrome) compared with placebo; (2) To preliminarily evaluate the safety of Changji'an Capsules in treating irritable bowel syndrome (diarrhea type) (liver depression and spleen deficiency syndrome); (3) To explore the optimal dose of Changji'an Capsules in treating irritable bowel syndrome (diarrhea type) (liver depression and spleen deficiency syndrome).

Start Date09 Dec 2015

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

100 Clinical Results associated with Changji'an Capsule

100 Translational Medicine associated with Changji'an Capsule

100 Patents (Medical) associated with Changji'an Capsule

Literatures (Medical) associated with Changji'an Capsule

01 Jul 2013·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effect of changji'an capsule on mRNA expressions of NPY and ACTH contents in brain-gut axis of IBS-D model rats].

Article

Author: He, Jia-Lun ; Tang, Hong-Mei ; Li, De-Tang ; Fang, Cai-Fu ; Qiu, Zhen-Wen ; Liao, Xiao-Hong

OBJECTIVETo explore the effect of Changji'an Capsule (CA) on mRNA expressions of neuropeptide Y (NPY) in the hypothalamus and colon and serum levels of adreno-cortico-tropic hormone (ACTH) in rats of diarrhea predominant irritable bowel syndrome (IBS-D) model rats.METHODSTotally 48 SD rats were randomly divided into six groups, i.e., the normal control group, the model group, the Pinaverium Bromide group (PB, 0.018 g/kg), the high dose CA group (2.812 g/kg), the medium dose CA group (1.406 g/kg), and the low dose CA group (0.703 g/kg), 8 in each group. The IBS-D rat model was established by using separation of breast milk + stimulation of acetic acid + constraint of four limbs. Normal saline was given to rats in the normal control group and the model group. All medication lasted for 14 successive days by gastrogavage. The serum content of ACTH was detected by enzyme linked immunosorbent assay (ELISA). The expressions of NPY mRNA in the colon and the hypothalamus were detected using real-time fluorescence quantitative PCR.RESULTSCompared with the normal control group, the serum ACTH content significantly increased (P < 0.01), the NPY mRNA expression in the colon and the hypothalamus obviously decreased (P < 0.01) in the model control group. Compared with the model group, the serum ACTH obviously decreased in the high dose CA group, the medium dose CA group, and the PB group (P < 0.01, P < 0.05). The NPY mRNA expression in the colon and the hypothalamus were obviously up-regulated in the high dose CA group, the medium dose CA group, the low dose CA group, and the PB group (P < 0.05).CONCLUSIONSCA could modulate the abnormity of brain-gut axis of IBS-D rats possibly by up-regulating NPY mRNA expressions in the hypothalamus and the colon and down-regulating the ACTH content in the hypothalamic-pituitary-adrenal axis.

01 Sep 2008·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effect of changji'an on visceral hypersensitivity in rats with irritable bowel syndrome and its mechanism].

Article

Author: Wang, Jing ; Zhu, Qi ; Lai, Hua-mei

OBJECTIVETo explore the mechanism and efficiency of Changji'an (CJA) in treating irritable bowel syndrome through studying the relationship between serotonin transporter (SERT) and visceral hypersensitivity in rats.METHODSMale SD rats were randomly divided into 4 groups: the normal control group, the model group, the high-dosage and low-dosage CJA (CJAH and CJAL) groups. Visceral hypersensitivity model was established by colorectal distension. Normal saline and different doses of CJA were administrated to rats respectively, starting from the 10th day of modeling for 10 days. After then, the abdominal withdrawal reflex (AWR) was scored for semi-quantitative estimation of visceral sensitivity, and tissues of brain and colon were harvested for detecting expressions of SERT and serotonin (5-HT) with Western blot, real-time PCR and immunohistochemistry.RESULTSAs compared with the normal controls, in model rats, the AWR score and content of 5-HT in intestinal mucosa were higher (P < 0.05), protein and mRNA expressions of SERT in colon and nucleus raphes dorsalis (NRD) were lower (P < 0.05), but all these indexes were improved significantly after CJA treatment, either in the CJAH or CJAL group (all P < 0.05). Besides, the number of 5-HT energic neuron in the model group and CJA groups was lower than that in the normal control group (P < 0.05).CONCLUSIONCJA has therapeutic effect for improving visceral hypersensitivity in irritable bowel syndrome by way of regulating colonic expression of SERT and content of 5-HT.

100 Deals associated with Changji'an Capsule

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable bowel syndrome with diarrhea	Phase 2	CN	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	08 Oct 2018
Diarrhea	Phase 2	CN	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	09 Dec 2015

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