Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Shiwei Anshen Granules for Chronic Insomnia With Yin-Deficiency Fire-Hyperactivity and Heart-Kidney Disharmony Syndrome.

This is a multi-center, randomized, controlled clinical study inlcuding 240 subjects with chronic insomnia. The purpose of this study is to evaluate the efficacy and safety of Shiwei Anshen Granules (an Chinese herbal preparation) in patients with chronic insomnia. Eligible participants will be randomly assigned to receiving Shiwei Anshen Granules or the control group receiving placebo. All subjects will receive 2 weeks run-in period, followed 8 weeks of intervention and 2 weeks follow-up without treatment. The main outcome is the change in PSQI score before and after treatment. Safety indicators including routine blood, liver and kidney function and adverse events will be monitored throughout the study.

Start Date01 Nov 2026

Sponsor / Collaborator

Dongzhimen Hospital

[+7]

NCT07843030

/ Not yet recruitingEarly Phase 1IIT

Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress

The goal of this clinical study is to evaluate the effectiveness of JiaJian GuiShen Optimized Formula (JJGS) and explore its mechanisms involving m6A modification and oxidative stress in women with premature ovarian insufficiency (POI). The main question it aims to answer is:
Does JJGS improve ovarian function in women with POI after three menstrual cycles of treatment? Twenty-five women with POI will receive JJGS, and 20 healthy women will serve as controls. Changes in FSH, E2, LH, AMH, oxidative stress markers, plasma FTO levels, whole-blood RNA m6A levels, and symptom scores will be analyzed before and after treatment.

Start Date30 Sep 2026

Sponsor / Collaborator

Dongzhimen Hospital

NCT07841548

/ Not yet recruitingEarly Phase 1IIT

A Randomized and Double-blind Clinical Trial of Guishen Yijing Granules on the Modulation of Ovarian Function in Patients With Diminished Ovarian Reserve

This study is a multicenter, stratified block-randomized, double-blind, double-dummy clinical trial designed to evaluate the efficacy and safety of Guishen Yijing Granules in patients with diminished ovarian reserve (DOR) and kidney deficiency syndrome through multidimensional assessment of clinical outcomes before and after treatment.
A total of 120 patients with DOR will be recruited from the gynecology outpatient departments of Dongzhimen Hospital, Beijing University of Chinese Medicine; Xiyuan Hospital, China Academy of Chinese Medical Sciences; and Beijing Chaoyang Hospital, Capital Medical University. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group, with 60 participants in each group.
Participants in the experimental group will receive Guishen Yijing Granules plus a coenzyme Q10 placebo, whereas those in the control group will receive coenzyme Q10 plus a Guishen Yijing Granules placebo. Treatment will begin on day 5 of the menstrual cycle. For participants with amenorrhea, treatment will begin after pregnancy has been excluded. Each treatment cycle will consist of 21 consecutive days of medication. If menstruation occurs after completion of a treatment cycle, the next treatment cycle will begin on day 5 of the subsequent menstrual cycle. If menstruation does not occur, participants will discontinue treatment for 7 days after pregnancy has been excluded and then begin the next treatment cycle according to the same regimen. Treatment will continue for three menstrual cycles; participants with amenorrhea will receive treatment for 3 months.
Outcomes assessed before and after treatment will include basal serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels, anti-Müllerian hormone (AMH), antral follicle count (AFC), traditional Chinese medicine syndrome scores, and modified Kupperman Index scores. The study aims to evaluate the efficacy and safety of Guishen Yijing Granules and their effects on ovarian function in patients with DOR.

Start Date22 Sep 2026

Sponsor / Collaborator

Dongzhimen Hospital

100 Clinical Results associated with Dongzhimen Hospital

0 Patents (Medical) associated with Dongzhimen Hospital

227

Literatures (Medical) associated with Dongzhimen Hospital

01 Nov 2026·PHYTOMEDICINE

M-SYFSF attenuates diabetic kidney disease by suppressing Piezo1-associated cGAS–STING signalling and tubular pyroptosis

Article

Author: Li, Chunyao ; Wu, Xiaochang ; Sun, Weiwei ; Wei, Shuwu ; Chen, Huixi ; Jiang, Weimin ; Liu, Weijing ; Zhou, Mengqi ; Zheng, Huijuan ; Li, Yaotan ; Wang, Yaoxian ; Zhang, Xinghua ; Hou, Jinyi ; Fu, Yuchen ; Wang, Lin

BACKGROUND:

Diabetic kidney disease (DKD) is a major cause of chronic kidney disease (CKD) worldwide, characterised by tubular injury, inflammation, and fibrosis. Increasing evidence suggests that mechanotransduction and innate immune activation contribute to DKD progression. However, the mechanistic link between mechanosensitive ion channels, cGAS-STING signalling, and pyroptosis remains incompletely understood.

PURPOSE:

This study aimed to investigate whether the modified Shen-Yan-Fang-Shuai formula (M-SYFSF) attenuates DKD and to explore its potential regulatory effects on Piezo1-mediated Ca²⁺ signalling, cGAS-STING activation, and tubular pyroptosis.

METHODS:

DKD was induced in rats by unilateral nephrectomy combined with streptozotocin injection, with valsartan as a positive control, and HK-2 cells were stimulated with advanced glycation end products (AGEs). Renal function, histopathology and fibrosis were assessed by biochemical assays and histological staining. Renal transcriptome sequencing, network pharmacology and analysis of public human renal transcriptomic datasets were used to identify candidate pathways. Western blotting, immunohistochemistry, immunofluorescence, qRT-PCR, Fluo-4 AM calcium imaging, ELISA, serum LDH activity and renal caspase-1 activity assays were performed to evaluate Piezo1 expression, cGAS-STING signalling and pyroptosis. Piezo1 knockdown and pharmacological modulation were used to assess pathway ordering, and Co-IP was used to examine the cGAS-STING association. Molecular docking and molecular dynamics simulation were performed as exploratory, hypothesis-generating analyses.

RESULTS:

DKD rats exhibited renal dysfunction, increased fibrosis, elevated Piezo1 expression, increased intracellular Ca²⁺ levels, activation of cGAS-STING signalling and upregulation of pyroptosis-associated proteins. Renal transcriptome sequencing and network pharmacology converged on mechanotransduction- and AGE-RAGE-associated pathways, and Piezo1 upregulation was further confirmed in db/db and HFD + STZ mice and in human tubulointerstitial datasets. M-SYFSF treatment improved renal function, attenuated fibrosis, reduced Piezo1 expression and intracellular Ca²⁺ accumulation, and suppressed cGAS-STING signalling and downstream inflammatory responses. Piezo1 knockdown attenuated STING and GSDMD-N upregulation, which was partially restored by Yoda1, whereas the STING inhibitor H-151 suppressed both STING and pyroptotic responses. Co-IP analysis showed an AGEs-induced cGAS-STING association that was reduced by M-SYFSF.

CONCLUSION:

M-SYFSF attenuated experimental DKD in association with reduced Piezo1-associated Ca²⁺ signalling, cGAS-STING activation and tubular pyroptosis-associated responses, and Piezo1 upregulation was reproducible across three rodent models and in human renal tissue. The data support an upstream contribution of Piezo1 under AGEs stress but do not establish the genetic necessity of STING, the proposed mitochondrial DNA intermediate, or the occurrence of fully executed pyroptosis.

01 Oct 2026·Chemical Biology & Drug Design

Mechanism of Qianlie Zhitong Formula Against Chronic Prostatitis Based on Proteomics and Metabolomics

Article

Author: Chang, Linhan ; Zheng, Yanfei ; Shen, Tiantong ; Zheng, Chenglong ; Dong, Lidan ; Wang, Qi ; Ding, Zhen ; Yan, Jialin ; Liu, Yunyu ; Song, Caijia

ABSTRACT:

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent pelvic pain disorder in men, yet effective pharmacotherapies remain limited. Emerging evidence suggests that oxidative stress and dysregulated iron metabolism contribute to the pathogenesis of CP/CPPS, with ferroptosis increasingly implicated in CP/CPPS‐related pathology. Qianlie Zhitong Formula (QLZTF) has shown therapeutic potential in treating CP/CPPS; however, its underlying mechanisms remain incompletely understood. This study integrated proteomics, metabolomics, and in vivo experiments to investigate the therapeutic mechanisms of QLZTF. A carrageenan‐induced rat model was established, and rats were randomly assigned to five groups: control, model, Qianliekang, low‐dose QLZTF, and high‐dose QLZTF. QLZTF significantly reduced inflammatory cytokines (TNF‐α, IL‐6, and IL‐1β), alleviated pain responses, and ameliorated prostate tissue injury. Proteomic analysis identified BCAT2, ALDH1B1, and ALDH2 as significantly upregulated proteins closely associated with ferroptosis. KEGG enrichment analysis of both proteomic and metabolomic data revealed that pantothenate and CoA biosynthesis and branched‐chain amino acid (BCAA) degradation pathways were significantly enriched. Integrated analysis indicated that QLZTF synergistically regulates these pathways, activates the BCAT2/ALDH axis, and inhibits ferroptosis, thereby alleviating inflammation, pain, and fibrosis in CP/CPPS. This study provides the first multiomics evidence for the anti‐ferroptotic mechanism of QLZTF.

01 Sep 2026·EXPERIMENTAL GERONTOLOGY

Astragalus membranaceus and Salvia miltiorrhiza injections confer cardioprotection via SERCA/SIRT1–mediated Ca2+ regulation

Article

Author: Cai, Yi ; Chang, Peifen ; Yuan, Wenjuan ; Zhao, Mingjing ; Guo, Nan ; Xiu, Shengyao ; Zhao, Yingkun

OBJECTIVE:

This study aimed to compare the distinct cardioprotective mechanisms of Astragalus membranaceus (AM) and Salvia miltiorrhiza (SM) injections in myocardial ischemia.

METHODS:

Male Sprague-Dawley rats were subjected to left anterior descending (LAD) coronary artery ligation to establish a myocardial ischemia model, followed by daily administration of AM or SM (intraperitoneal injection, 4 g/kg) for 14 days. Cardiac function and remodeling were evaluated via echocardiography and histopathological staining. Platelet aggregation, intracellular Ca²⁺ dynamics, and sarco/endoplasmic reticulum Ca²⁺-ATPase (SERCA) and sirtuin 1 (SIRT1) signaling were analyzed using optical aggregometry, calcium assays, flow cytometry, fluorescence imaging, and Western blotting. Endothelial integrity and function were assessed by measuring the expression of zonula occludens-1 (ZO-1), endothelial nitric oxide synthase (eNOS), von Willebrand factor (vWF), and tumor necrosis factor-α (TNF-α) via immunofluorescence and immunohistochemistry. Additionally, lipopolysaccharide (LPS)-stimulated human umbilical vein endothelial cells (HUVECs) were utilized to model endothelial injury in vitro. Pharmacological inhibitors were employed to validate pathway specificity, and molecular docking was performed to predict binding interactions between key bioactive constituents of AM/SM and their SERCA/SIRT1 targets.

RESULTS:

Both AM and SM improved cardiac function, reduced fibrosis, inhibited platelet aggregation, and alleviated endothelial dysfunction in ischemic rats. AM primarily enhanced SERCA expression and Ca²⁺ reuptake, resulting in improved endothelial barrier preservation, whereas SM preferentially activated SIRT1 signaling, with greater anti-inflammatory effects. Both treatments reduced Ca²⁺ overload in platelets and HUVECs, which were partially reversed by SERCA or SIRT1 inhibition. Molecular docking further supported preferential targeting of SERCA by AM-derived compounds and SIRT1 by SM-derived compounds.

CONCLUSION:

AM and SM injections confer cardioprotection by differentially modulating SERCA and SIRT1 to stabilize cytosolic Ca²⁺.

News (Medical) associated with Dongzhimen Hospital

19 Jun 2023

·www.prnewswire.com

An Integration of Traditional Chinese Medicine and Modern Medicine Realized by Dongzhimen Hospital of Beijing University of Chinese Medicine

BEIJING, June 19, 2023 /PRNewswire/ -- A news report by haiwainet.cn: Beijing College of Traditional Chinese Medicine (now Beijing University of Traditional Chinese Medicine) and Dongzhimen Hospital, one of its affiliates, cooperated with The Staudinger Company Group in establishing the TCM-Klinik Bad Kötzting, the first licensed TCM hospital in Germany. In terms of patient diagnosis and treatment, the hospital always gives priority to curative effects, and treats patients under the guidance of TCM theories and concepts, showcasing the features and advantages of TCM with successful practices. When it comes to TCM publicity, the hospital has hosted various activities that attracted people in the local area and from neighboring countries, as well as wide coverage by foreign media. In this way, the hospital contributed to the dissemination of TCM overseas. In 2008, the hospital was bestowed with the the 2008 International Award for Contribution to Chinese Medicine, the highest award in the field of international TCM cooperation, by the World Federation of Chinese Medicine Societies (WFCMS). This honor highlighted the great contribution made by the hospital to TCM publicity and education. Promoting the integration of TCM and Modern Medicine Adhering to the concepts of offering patient-centered therapies and combining prevention and treatment, the hospital is committed to safeguarding the health of patients with "the essence in the two schools of medicine", and conducing to the integration of TCM medicine and modern medicine. With regard to exchanges between TCM and Western medicine, the hospital has carried out in-depth discussions with medical institutions worldwide, and co-founded the China-Europe TCM Cooperation and Development Forum with the WFCMS. All these efforts have injected vitality into TCM in its process to become modern and go global. In terms of scientific research on TCM, the hospital has published a total of 156 articles and monographs, and formulated or compiled many standards and other relevant materials, in order to promote standardization in TCM education and research. This also facilitates the integration of TCM and modern medicine. By unremittingly exploring how to integrate TCM and modern medicine and delving deeply into research on TCM, the hospital has emerged as a pioneer in terms of introducing TCM to the world, a bridge for the communication between Chinese and Western cultures, and a contributor to the implementation of the Belt and Road Initiative. SOURCE haiwainet.cn

100 Deals associated with Dongzhimen Hospital

100 Translational Medicine associated with Dongzhimen Hospital

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Xinglou Chengqi Granules	Acute Ischemic Stroke More	Phase 2
Acteoside ( AHR x HMGB1 x NLRP3 x PKC x TLR4 )	Diabetic Nephropathies More	Preclinical
CN122127267 ( CES2 )Patent Mining	Neoplasms More	Discovery
Tianmabianchunzhigan	Dementia, Vascular More	Pending

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