A Randomized, Double-blind, Positive-Controlled Study to Evaluate the Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases

Randomized, double blind and positive-controlled clinical trial to assess the efficacy and safety of Fuke Qianjin Capsule compared to Doxycycline Hyclate Tablet in patients with mild to medium PID and its sequalae.

Start Date21 Sep 2021

Sponsor / Collaborator

University of Karachi

[+2]

100 Clinical Results associated with Fuke Qianjin Capsule

100 Translational Medicine associated with Fuke Qianjin Capsule

100 Patents (Medical) associated with Fuke Qianjin Capsule

Literatures (Medical) associated with Fuke Qianjin Capsule

01 Jan 2025·Journal of Ethnopharmacology

FuKe QianJin capsule alleviates endometritis via inhibiting inflammation and pyroptosis through modulating TLR4/ NF-κB /NLRP3 pathway

Article

Author: Li, Yamei ; Xu, Chunfang ; Xia, Bohou ; Xie, Jingchen ; Xiong, Suhui ; Liao, Yingyan ; Yang, Chen ; Li, Chun ; Lin, Limei ; Luo, Hongshan ; Zhang, Zhimin

ETHNOPHARMACOLOGICAL RELEVANCEFuke Qianjin Capsule (FKC), a traditional Chinese medicine commonly employed for treating endometritis, lacks reported treatment mechanisms.AIM OF THE STUDYThe aim of the present study was to explore the role and mechanism of FKC in lipopolysaccharide (LPS)-induced endometritis.MATERIALS AND METHODSThe main active ingredients of FKC were identified via high-performance liquid chromatography (HPLC) in conjunction with standard substances. Prior to endometritis induction, Sprague Dawley female rats received FKC for 7 days. The endometritis model was established through an intrauterine injection of 1 mg/kg LPS. Concurrently, an LPS-induced RAW264.7 cell inflammation model was utilized, in which the cells were treated with serum containing Fuke Qianjin Capsule. Pathological alterations in the endometrium were assessed via H&E staining and transmission electron microscopy (TEM). The contents of MPO in uterine tissues, and NO release in cells, along with the secretion of IL-18, IL-1β, IL-6, and TNF-α in both tissues and cells, were determined via assay kits. The mRNA levels of Nlrp3, Caspase-1, Gsdmd, and Il-1β in uterine tissues and cells were analyzed via qPCR. The protein levels of TLR4, p65, p-P65, NLRP3, Caspase-1, GSDMD, and IL-1β in these samples were evaluated through Western blot analysis. Immunofluorescence was used to assess the protein levels of p-P65 and NLRP3 in uterine tissues and cells.RESULTSFive primary active components of FKC were identified. Treatment with FKC in vivo mitigated endometrial pathological damage and significantly decreased the levels of MPO, IL-18, IL-1β, IL-6, and TNF-α, as well as the levels of Nlrp3, Caspase-1, Gsdmd, and Il-1β mRNA in tissue samples. Treatment with FKC inhibited the expression of TLR4, p-P65, NLRP3, Caspase-1, GSDMD, and IL-1β, as well as reduced NLRP3 protein fluorescence intensity, and inhibited P65 phosphorylation. In vitro findings demonstrated that FKC-containing serum reduced IL-18, IL-1β, IL-6, and TNF-α levels, as well as reduced Nlrp3, Caspase-1, Gsdmd, and Il-1β mRNA levels. In addition, FKC-containing serum inhibited the protein expression of TLR4, p-P65, NLRP3, Caspase-1, GSDMD, and IL-1β. FKC-containing serum also reduced NLRP3 protein fluorescence intensity and suppressed P65 phosphorylation.CONCLUSIONFKC reverses the LPS induced NLRP3 inflammasome activation, and mitigates inflammation and pyroptosis through the modulation of the TLR4/NF-κB/NLRP3 pathway, thereby alleviating endometritis.

01 Nov 2024·Journal of Ethnopharmacology

New idea of Fuke Qianjin capsule in treating sequelae of pelvic inflammatory disease: anti-inflammatory in the early stage and reparative in the later stage

Article

Author: Li, Yamei ; Xu, Chunfang ; Zhang, Zhimin ; Wu, Mengyao ; Xia, Bohou ; Liao, Duanfang ; Gong, Yun ; Lin, Limei ; Xiang, Feng ; Zhang, Peng ; Yi, Meijin ; Xiao, Zhikui ; Su, Liang ; Zheng, Yuanqing ; Liao, Yingyan

ETHNOPHARMACOLOGICAL RELEVANCESequelae of pelvic inflammatory disease (SPID) occurs in female internal genitalia and surrounding connective tissue. Recent clinical studies have shown that the traditional Chinese medicine Fuke Qianjin capsule (FKQ) can shorten the course of this disease, but its pharmacological effects and potential mechanism have not been fully elucidated.AIM OF THE STUDYThis study aimed to investigate the efficacy and underlying mechanisms of FKQ in the treatment of SPID.METHODSIn this study, we first established a mixed infection model to explore the protective effect of FKQ on common pathogens of SPID. Afterwards, mixed bacterial infection and mechanical injury were used in a SPID rat model to explore the protective mechanism of FKQ on SPID rats. Inflammation, repair and immune cells were tested.RESULTSFKQ has a protective effect against infections caused by SPID pathogenic bacterial and may reduce mortality from mixed infections. In the SPID model, FKQ improved pathological damage to the uterus, reduced the area of uterine fibrosis, and inhibited the levels of cytokines (TNF-α, IL-6, IL-1β, IL-18, TGF-β1 and VEGF) caused by pathogenic bacteria. Moreover, FKQ treatment reduced the accumulation of NLRP3, Caspase-1, GSDMD Vimentin, and Cytokeratin 18 in the uterus and suppressed the expression of TGF-β1 and VEGF in the fallopian tubes, thereby reducing inflammation and promoting mucosal repair. In addition, FKQ can restore the immune function balance of SPID rats by increasing the proportion of Treg cells in the spleen and thymus in a rat model of SPID, reducing the proportion of Th17 lymphocytes, and promoting an immunological balance of Treg/Th17 cells, thereby regulating the immune system of the body.CONCLUSIONIn summary, FKQ treatment for SPID is the result of a fourfold combination of antibacterial, anti-inflammatory, reparative and immune-enhancing activities.

01 Jun 2024·Journal of Pharmaceutical and Biomedical Analysis

Pharmacokinetic and tissue distribution analysis of bioactive compounds from Fuke Qianjin capsules in rats by a validated UPLC MS/MS method

Article

Author: Zhang, Peng ; Guo, Xiujie ; Wu, Mengyao ; Yang, Jiaying ; Gong, Yun ; Wang, Chaoran ; Zheng, Yuanqing ; Wang, Wei

Fuke Qianjin capsules (FKQJ) exhibit obvious advantages and characteristics in the treatment of pelvic inflammatory disease. At present, information regarding the in vivo process of FKQJ is lacking, which has become a bottleneck in further determining the therapeutic effect of this traditional Chinese medicine. In the present study, a sensitive, simple and reliable method was developed and validated for the simultaneous quantification of 12 main components (4 flavonoids, 4 alkaloids, 2 phthalides and 2 diterpene lactones) in plasma and seven tissues of rats to study the pharmacokinetic and distribution characteristics of these components in vivo by using ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for the first time. Plasma and tissue were prepared by protein precipitation with acetonitrile and methanol, followed by its separation on a Waters Acquity UPLC BEH C₁₈ column. The quantification was performed via multiple reaction monitoring (MRM) by a triple quadrupole mass spectrometer under positive electrospray ionization (ESI) mode. The method was validated to demonstrate its selectivity, linearity, accuracy, precision, recovery, matrix effect and stability. For 12 analytes, the low limit of quantification (LLOQs) reached 0.005-2.44 ng/mL, and all calibration curves showed good linearity (r² ≥ 0.990) in linear ranges. The intra-day and inter-day precision (relative standard deviation) for all analytes was less than 14.96%, and the accuracies were in the range of 85.29%-114.97%. Extraction recoveries and matrix effects of analytes were acceptable. The pharmacokinetic results showed that the main components could be absorbed quickly, had a short residence time, and were eliminated quickly in vivo. At different time points, the 12 components were widely distributed with uneven characteristics in the body, which tended to be distributed in the liver, kidney and lung and to a lesser extent in the uterus, brain and heart. The pharmacokinetic process and tissue distribution characteristics of FKQJ were expounded in this study, which can provide a scientific theory for in-depth development of FKQJ and guide FKQJ use in the clinic.

100 Deals associated with Fuke Qianjin Capsule

R&D Status

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Indication	Country/Location	Organization	Date
Endometritis	CN	Zhuzhou Qianjin Pharmaceutical Co., Ltd.	30 May 2019
Uterine Cervicitis	CN	Zhuzhou Qianjin Pharmaceutical Co., Ltd.	30 May 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pelvic Inflammatory Disease	Discovery	PK	Zhuzhou Qianjin Pharmaceutical Co., Ltd.	21 Sep 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04723069 (Pubmed) Manual	Phase 2	Pelvic Inflammatory Disease	198	metronidazole + doxycycline hyclate +Fuke Qianjin (FUKE) capsule	efgpatesju(yovlqotbzb) = ftqctxzmvw zewedwamma (bheqxgpnkw ) View more	Positive	01 Jan 2024
				metronidazole + doxycycline hyclate + FUKE simulant capsules	efgpatesju(yovlqotbzb) = fpxmytsbwp zewedwamma (bheqxgpnkw ) View more

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