[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial on the efficacy and safety of Yifei Jisheng Granules in the treatment of chronic obstructive pulmonary disease (lung and kidney qi deficiency syndrome)

探索性评价益肺济生颗粒治疗慢性阻塞性肺疾病（COPD）稳定期（肺肾气虚证）的有效性和安全性。

[Translation]

To explore the efficacy and safety of Yifei Jisheng Granule in the treatment of stable chronic obstructive pulmonary disease (COPD) (lung and kidney qi deficiency syndrome).

Start Date18 Aug 2023

Sponsor / Collaborator

Henan University of Traditional Chinese Medicine

100 Clinical Results associated with Yifei Jisheng Granules

100 Translational Medicine associated with Yifei Jisheng Granules

100 Patents (Medical) associated with Yifei Jisheng Granules

Literatures (Medical) associated with Yifei Jisheng Granules

13 Feb 2023·Journal of Oncology

Deciphering the Molecular Mechanism of Yifei-Sanjie Pill in Cancer-Related Fatigue

Article

Author: Wang, Wuhong ; Ye, Huan ; Pi, Dajin ; Zhou, Shuyao ; Chen, Yiliu ; Dong, Yangyang ; Ouyang, Mingzi ; Wu, Yingchao ; Yi, Zhongjia ; Lin, Lizhu

Background. The incidence of cancer-related fatigue (CRF) is increasing, but its lack of clear pathogenesis makes its prevention and treatment difficult. Therefore, it is of great significance to clarify the pathogenesis of CRF and find effective methods to treat it. Methods. The CRF model was established by intraperitoneal injection of LLC cells in ICR mice to explore the pathogenesis of CRF and verify the therapeutic effect of the Yifei-Sanjie pill (YFSJ). The active components of YFSJ were found by LC/MS, the in vitro inflammatory infiltration model of skeletal muscle was constructed by TNF-α and C2C12 myoblasts, and the results of in vivo experiments were verified by this model. Results. Behavioral analysis results showed that YFSJ alleviated CRF; histological examination results showed that YFSJ could reverse the tumor microenvironment leading to skeletal muscle injury; ELISA and RNA-seq results showed that the occurrence of CRF and the therapeutic effect of YFSJ were closely related to the tumor inflammatory microenvironment; IHC and WB results showed that the occurrence of CRF and the therapeutic effect of YFSJ were closely related to the Stat3-related signaling pathway and autophagy. Conclusions. YFSJ can reduce the level of inflammation in the tumor microenvironment in vivo, inhibit the abnormal activation of the Stat3/HIF-1α/BNIP3 signaling pathway induced by tumor-related inflammation, thereby inhibiting the overactivation of mitophagy in skeletal muscle, and finally alleviate CRF. Quercetin, one of the components of YFSJ, plays an important role in inhibiting the phosphorylation activation of Stat3.

01 Jan 2023·Integrative Cancer Therapies

Yifei Sanjie Formula or Placebo With Anlotinib as Second-Line or Above Treatment for Metastatic Non-Small-Cell Lung Cancer: Study Protocol for a Double-Blind, Placebo-Controlled Randomized Pilot Study

Article

Author: xin Zhang, Ze ; Tao, Lanting ; Xiao, Zhiwei ; Qi, Xiangjun ; Chen, Hanrui ; Lin, Jietao ; Sun, Lingling ; Yang, Ting ; Cao, Yang ; Chen, Wenmin ; Lin, Lizhu

Background: Anlotinib is used as a third-line treatment for advanced non-small-cell lung cancer (NSCLC), but has limited clinical benefits and several side effects, such as diarrhea and acneiform skin rash. Traditional Chinese Medicine (TCM) is commonly used to treat cancers in China. Chinese herbal medicines may have the potential as adjuvant therapies to reduce toxicity and improve the efficacy of treatments for NSCLC. Given the positive outcomes of basic research, we plan to evaluate whether the addition of the Chinese herbal medicine Yifei Sanjie formula (YFSJF) to anlotinib can improve the progression-free survival (PFS) of advanced NSCLC patients. Methods: A multicenter, randomized, double-blind, placebo-controlled parallel-group controlled pilot trial will be performed. Forty eligible patients will be randomized in a ratio of 1:1 to the intervention (YFSJF + anlotinib) and control (placebo + anlotinib) groups. Participants will be advised to take 12 mg/day of anlotinib on days 1 to 14 of each 21-day cycle. YFSJF or placebo will be administered (15 g twice daily) during each cycle until progression of disease (PD). The primary outcome will be progression-free survival (PFS), and the secondary outcomes will be overall survival (OS), the objective response rate (ORR), and patient-reported outcomes (PRO). Tumors will be assessed based on RECIST v. 1.1 after every 2 cycles of treatment. The M. D. Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to evaluate PRO at baseline and weekly thereafter until PD. Discussion: This will be the first trial to evaluate the effectiveness and safety of TCM combined with anlotinib for the treatment of NSCLC. The results of this randomized controlled trial will fill a gap in the research by showing whether YFSJF combined with anlotinib can improve PFS in NSCLC patients. Trial Registration: The study was registered on June 8th, 2021 on Chinese Clinical Registry; registration number ChiCTR2100047143. ( https://www.chictr.org.cn/index.aspx ). Ethics and Dissemination: The Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine approved the study protocol (approval no.: K2020151, 2021/08/19). The study will also be supervised and managed by the Ethics Committee.

100 Deals associated with Yifei Jisheng Granules

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Henan University of Traditional Chinese Medicine	18 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data