A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Shenqi Sherong Pill in Cervical Spondylotic Myelopathy (Qi Deficiency, Blood Stasis and Kidney Deficiency Type)

The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration.

Start Date11 May 2024

Sponsor / Collaborator

Shanghai Hutchison Pharmaceuticals Co., Ltd.

CTR20241014 / RecruitingPhase 3

参芪麝蓉丸治疗轻、中度脊髓型颈椎病（气虚血瘀肾亏证）有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Shenqi Sherong Pills in the treatment of mild and moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome)

以安慰剂为对照，验证参芪麝蓉丸治疗轻、中度脊髓型颈椎病（气虚血瘀肾亏证）的有效性和安全性，为申请药品上市提供依据

[Translation]

Using placebo as control, verify the effectiveness and safety of Shenqi Sherong Pills in treating mild and moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome), and provide a basis for applying for drug marketing

Start Date10 May 2024

Sponsor / Collaborator

Longhua Hospital Shanghai University of TCM

[+1]

CTR20210406 / CompletedPhase 2

参芪麝蓉丸治疗轻、中度脊髓型颈椎病（气虚血瘀肾亏证）有效性和安全性的随机、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 on the efficacy and safety of Shenqi Sherong Pills in the treatment of mild and moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome)

以安慰剂为对照，评价参芪麝蓉丸治疗轻、中度脊髓型颈椎病（气虚血瘀肾亏证）的有效性和安全性，为 III 期临床试验设计提供依据。

[Translation]

Using placebo as control, this study evaluated the efficacy and safety of Shenqi Sherong Pills in the treatment of mild to moderate cervical spondylotic myelopathy (Qi deficiency, blood stasis, and kidney deficiency syndrome) and provided a basis for the design of Phase III clinical trials.

Start Date02 Jul 2021

Sponsor / Collaborator

Longhua Hospital Shanghai University of TCM

[+1]

100 Clinical Results associated with Shenqi Sherong Pills

100 Translational Medicine associated with Shenqi Sherong Pills

100 Patents (Medical) associated with Shenqi Sherong Pills

Literatures (Medical) associated with Shenqi Sherong Pills

09 Aug 2024·Endocrine, Metabolic & Immune Disorders - Drug Targets

Elucidating the Mechanism of Jisheng Shenqi Pills in the Treatment of Diabetic Kidney Disease: Network Pharmacology Combined with Experimental Verification

Article

Author: Zhou, Guangju ; Ma, Xiaoshu

Background:While the annual incidence of diabetic kidney disease (DKD) has been soaring, the exact mechanisms underlying its onset and progression remain partially understood.Objective:The present study delved into the underlying mechanisms of Jisheng Shenqi Pill (JSP) in the treatment of DKD.Methods:The active constituents and prospective targets of JSP were identified from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), while DKD-associated disease targets were obtained from the GeneCards database. Subsequently, Gene Ontology (GO) functional annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were performed to assess the overlapping segment of drugs and disease targets. Meanwhile, a component-target-pathway network was constructed to identify pivotal components, targets, and pathways. Molecular docking and molecular dynamics simulation were also carried out to validate the binding efficacy of the pivotal components with the targets. Finally, animal experiments were conducted to corroborate the efficacy of the aforementioned targets and pathways.Results:According to bioinformatics analysis, the primary targets included JUN, TNF, and BAX, while the pivotal pathways involved were AGE/RAGE and PI3K/AKT signaling cascades. In vivo experiments demonstrated that JSP effectively mitigated renal impairment in DKD by reducing renal inflammation and apoptosis. This effect was presumably achieved by modulating the AGERAGE axis and the PI3K/AKT signaling pathway.Conclusion:Our findings imply that JSP could ameliorate renal inflammation and apoptosis in DKD mice by modulating the AGE/RAGE axis and the PI3K/AKT signaling pathway. These findings provide valuable insights into traditional Chinese medicine-based treatments for DKD.

15 Nov 2019·Journal of Immunology ResearchQ3 · MEDICINE

Efficacy of Shenqi Pollen Capsules for High-Altitude Deacclimatization Syndrome via Suppression of the Reoxygenation Injury and Inflammatory Response

Q3 · MEDICINE

ArticleOA

Author: Wang, Guansong ; Guo, Liang ; He, Binfeng ; Luo, Yongjun ; Lin, Kexiong ; Zi, Yunhai ; Hu, Mingdong ; Li, Qi ; Dong, Zhiwei ; Liu, Zhenyu ; Liang, Zhihui ; Ma, Qianli ; Qian, Guisheng

High-altitude deacclimatization syndrome (HADAS) is involved in hypoxia-reoxygenation injury and inflammatory response, induced a series of symptoms, and has emerged as a severe public health issue. Here, we investigated the mechanism as well as potential means to prevent HADAS using Shenqi pollen capsules (SPCs) in subjects with HADAS in a multicenter, double-blinded, randomized, placebo-controlled study. All subjects were at the same high altitude (3650 m) for 4-8 months before returning to lower altitudes. Subjects (n=288) in 20 clusters were diagnosed with mild or moderate HADAS on the third day of the study. We randomly allocated 20 clusters of subjects (1 : 1) to receive SPCs or a placebo for 7 weeks, and they were then followed up to the 14th week. The primary endpoints were subjects’ HADAS scores recorded during the 14 weeks of follow-up. Compared with the placebo, SPC treatment significantly decreased the subjects’ HADAS scores and reduced the incidence of symptom persistence. SPC therapy also reduced the serum levels of CK, CK-MB, LDH, IL-17A, TNF-α, and miR-155 and elevated IL-10 and miR-21 levels. We thus demonstrate that SPCs effectively ameliorated HADAS symptoms in these subjects via suppression of the hypoxia-reoxygenation injury and inflammatory response.

01 Jan 2017·BioScience TrendsQ4 · BIOLOGY

Shenqi detoxification granule combined with P311 inhibits epithelial-mesenchymal transition in renal fibrosis <i>via</i> TGF-β1-Smad-ILK pathway

Q4 · BIOLOGY

Article

Author: Xu, Yuan ; Si, Guomin ; Qi, Fanghua ; Liu, Xiang ; Cai, Pingping

Shenqi detoxification granule (SDG), a traditional Chinese herbal formula, has been shown to have nephroprotective and anti-fibrotic activities in patients with chronic kidney disease (CKD). However, its mechanisms in renal fibrosis and the progression of CKD remain largely unknown. P311, a highly conserved 8-kDa intracellular protein, plays a key role in renal fibrosis by regulating epithelial-mesenchymal transition (EMT). Previously, we found P311 might be involved in the pathogenesis of renal fibrosis by inhibiting EMT via the TGF-β1-Smad-ILK pathway. We also found SDG combined with P311 could ameliorate renal fibrosis by regulating the expression of EMT markers. Here we further examined the effect and mechanism of SDG combined with P311 on TGF-β1-mediated EMT in a rat model of unilateral ureteral occlusion (UUO) renal fibrosis. After establishment of the UUO model successfully, the rats were gavaged with SDG daily and/or injected with recombinant adenovirus p311 (also called Ad-P311) through the tail vein each week for 4 weeks. Serum creatinine (Cr), blood urea nitrogen (BUN) and albumin (ALB) levels were tested to observe renal function, and hematoxylin eosin (HE) and Masson staining were performed to observe kidney histopathology. Furthermore, the expression of EMT markers (E-cadherin and α-smooth muscle actin (α-SMA)) and EMT-related molecules TGF-β1, pSmad2/3, Smad7 and ILK were observed using immunohistochemical staining and Western blot analysis. Treatment with SDG and P311 improved renal function and histopathological abnormalities, as well as reversing the changes of EMT markers and EMT-related molecules, which indicated SDG combined with P311 could attenuate renal fibrosis in UUO rats, and the underlying mechanism might involve TGF-β1-mediated EMT and the TGF-β1-Smad-ILK signaling pathway. Therefore, SDG might be a novel alternative therapy for treating renal fibrosis and delaying the progression of CKD. Furthermore, SDG combined with P311 might have a synergistic effect on attenuating renal fibrosis.

100 Deals associated with Shenqi Sherong Pills

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Indication	Highest Phase	Country/Location	Organization	Date
Blood Stasis	Phase 3	CN	Shanghai Hutchison Pharmaceuticals Co., Ltd.	11 May 2024
Cervical myelopathy	Phase 3	CN	Shanghai Hutchison Pharmaceuticals Co., Ltd.	10 May 2024
Cervical myelopathy	Phase 3	CN	Longhua Hospital Shanghai University of TCM	10 May 2024

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