A multicenter, open label, randomized controlled exploratory clinical trial to evaluate the efficacy and safety of combination therapy with Bojungikki-tang and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer

Start Date15 Mar 2024

Sponsor / Collaborator-

NCT06249854 / RecruitingPhase 2IIT

A Multicenter, Open Label, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations.
Based on prior pre-clinical studies, the combination of Bojungikki-tang and immune checkpoint inhibitors (ICIs) can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment.
Therefore, this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment.

Start Date08 Feb 2024

Sponsor / Collaborator

Korea Institute of Oriental Medicine

KCT0006689 / CompletedPhase 2IIT

Safety and efficacy of Bojungikki-tang in advanced NSCLC patients receiving treatment with immune checkpoint inhibitors: A study protocol for a multicenter, double-blind, randomized, placebo-controlled pilot trial

Start Date11 May 2022

Sponsor / Collaborator-

100 Clinical Results associated with Bu Zhong Yi Qi Tang

100 Translational Medicine associated with Bu Zhong Yi Qi Tang

100 Patents (Medical) associated with Bu Zhong Yi Qi Tang

123

Literatures (Medical) associated with Bu Zhong Yi Qi Tang

01 Nov 2024·Journal of Infection and Chemotherapy

Traditional Japanese herbal medicine Hochuekkito protects development of sepsis after nasal colonization in mice

Article

Author: Sakatani, Hideki ; Ogura, Keisuke ; Shiga, Tatsuya ; Hotomi, Muneki ; Murakami, Daichi ; Kono, Masamitsu

INTRODUCTIONStreptococcus pneumoniae, a commensal in the nasopharynx, can cause invasive pneumococcal diseases (IPDs). To prevent the aggravation of IPDs, it is important to enhance host immune defense against S. pneumoniae. Hochuekkito (HET) is expected to have an immunostimulatory effect against infections.METHODSHET was administrated by gavage to adult BALB/cA mice before and after intranasal inoculation of S. pneumoniae. We evaluated the effect of HET on pneumococcal nasal colonization and subsequent development of lethal pneumococcal infections.RESULTSNo effect on nasal colonization was observed, but HET significantly reduced bacterial count in the blood, decreased the incidence of bacteremia, and improved survival. HET also reduced nasal tissue damage 3 days after intranasal infection. Neutrophils from HET-treated mice showed significantly higher bactericidal activity against S. pneumoniae in the presence of the serum from the HET group compared with from the control group.CONCLUSIONSThe non-specific immunostimulatory effect of HET is suggested by this study to be effective in preventing the progression in IPDs and provided insights into novel strategy in the post-pneumococcal vaccine era.

01 Oct 2024·Phytomedicine

Quantitative ternary network-oriented discovery of Q-markers from traditional Chinese medicine prescriptions: Bu-Zhong-Yi-Qi-Tang as a case study

Article

Author: Chen, Jiali ; Lin, Pei ; He, Liangliang ; Yao, Xinsheng ; Zou, Zhenyu ; Hu, Liufang ; Chen, Guotao ; Tong, Xupeng ; Du, Jing ; Qiu, Yuan ; Yao, Zhihong ; Chen, Jiaxu

BACKGROUNDThe proposal of Q-markers for traditional Chinese medicine (TCM) represents a novel avenue of research pertaining to the quality control of TCM prescriptions. However, prior exploratory studies on Q-markers with multiple properties consistently neglected the consideration of weights, hampering our ability to accurately gauge the significance of each property and potentially leading to a flawed comprehension of Q-markers.PURPOSEIn this study, a quantitative ternary network strategy was firstly proposed to visually discover the Q-markers from TCM prescriptions, and it has been successfully applied into the quality control study of Bu-Zhong-Yi-Qi-Tang (BZYQT), a classical TCM prescription.METHODSFirstly, the contents of 34 components in BZYQT, along with the kinetic features of 17 candidate Q-markers in biosamples (plasma and small intestinal contents), were characterized by UPLC-QqQ-MS/MS, and their immunomodulatory activities in macrophages and splenic lymphocytes were also assessed. Next, the obtained data were integrated into three properties: testability, bioavailability, effectiveness, and their weights were calculated using the entropy weight method to further establish a ternary network for quantitatively screening Q-markers. Subsequently, the identified Q-markers of BZYQT were utilized for the holistic quality evaluation of 36 batches of the commercial BZYQT preparation, Bu-Zhong-Yi-Qi-Pill (BZYQP) produced by three manufacturers, through similarity evaluation of the Q-marker-based fingerprint.RESULTSNine compounds (hesperidin, astragaloside IV, ononin, 18β-glycyrrhizic acid, narirutin, calycosin, cimigenoside, astragaloside II, and liquiritin) showing three core properties, including testability, bioavailability, and effectiveness, were screened out as Q-markers of BZYQT based on their rankings in terms of regression area of the ternary network. Employing Q-markers as common peaks, the similarity values of 36 batches BZYQP ranged 0.914-0.998 under HPLC-UVD mode, and 0.631-1.000 under HPLC-ELSD mode, which were less than the similarity values evaluated by the conventional common peaks (HPLC-UVD mode: 0.946-0.990; HPLC-ELSD mode: 0.957-0.997). This observation suggests that the identified Q-markers are more representative as common peaks in chromatographic fingerprints for the holistic quality evaluation of TCM-related products from different manufacturers.CONCLUSIONThe quantitative discovery of Q-markers from BZYQT laid an important foundation for holistic quality assessment of its related commercially available products, and our work offering a new strategy for ensuring the consistency and efficacy of TCM prescriptions.

01 Oct 2024·Clinical Nutrition ESPEN

Effect of the Japanese herbal medicine Hochuekkito for systemic inflammation, prognostic nutrition index, and body composition status in patients with gastrointestinal cancer

Article

Author: Yoshiyama, Shigeyuki ; Toiyama, Yuji ; Shirai, Yumiko ; Fujiwara, Takumi ; Kawamura, Mikio ; Nahata, Miwa ; Okugawa, Yoshinaga ; Yasuda, Hiromi ; Fujitsuka, Naoki ; Kitajima, Takahito ; Ohi, Masaki ; Mochiki, Ikuyo ; Morimoto, Yuki ; Shimura, Tadanobu ; Mogami, Sachiko ; Imaoka, Hiroki ; Tanaka, Koji ; Fukumori, Kazutoshi ; Okita, Yoshiki

BACKGROUND & AIMSA systemic inflammatory response via host-tumor interactions is a cancer hallmark that plays a pivotal role in the pathogenesis of malnutrition and sarcopenia in patients with malignancies. Hochuekkito (TJ-41) is a traditional Japanese herbal medicine that modulates inflammation in patients with various chronic inflammatory diseases. However, the clinical efficacy of TJ-41 in patients with malignancies remains unclear.METHODSWe systemically analyzed chronological changes in levels of systemic inflammatory parameters, nutrition-related parameters, and body composition status in 99 patients who received TJ-41 treatment for more than 3 months. The cohort comprised 56 patients with gastrointestinal cancer (Cancer Cohort) and 43 with other diseases (Other Disease Cohort). We also performed in vivo experiments in mice to validate the clinical findings.RESULTSDespite no significant changes in serum albumin concentration and prognostic nutrition index, the serum C-reactive protein (CRP) concentration significantly decreased in a time-dependent manner in all patients. However, the serum CRP concentration significantly decreased during TJ-41 treatment in the Cancer Cohort but not the Other Disease Cohort. Furthermore, downregulation of CRP during TJ-41 treatment occurred only in patients with metastases. The psoas muscle index, as a muscle quantity marker, was significantly lower in the CRP-increased group compared with the CRP-decreased group during TJ-41 treatment. In vivo experiments using a Colon-26 syngeneic model showed that the plasma CRP, amyloid A, and interleukin-6 concentrations were significantly lower in the TJ-41 group than the control group.CONCLUSIONTJ-41 might be useful as part of multimodality therapy for gastrointestinal cancer, especially in patients with metastases.

100 Deals associated with Bu Zhong Yi Qi Tang

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Indication	Country/Location	Organization	Date
Anemia	JP	Sanwa Shoyaku Co., Ltd.	18 Jul 1986
Gastrointestinal Diseases	JP	Sanwa Shoyaku Co., Ltd.	18 Jul 1986
Hyperhidrosis	JP	Sanwa Shoyaku Co., Ltd.	18 Jul 1986
Hypotension	JP	Sanwa Shoyaku Co., Ltd.	18 Jul 1986

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