[Translation] A randomized, double-blind, placebo-controlled, multicenter phase IIa clinical study to evaluate the efficacy and safety of sodium salvianolic acid A for injection in myocardial protection in patients with acute myocardial infarction after PCI

评价注射用丹酚酸A钠用于急性心肌梗死患者PCI术后心肌保护的有效性与安全性

[Translation]

To evaluate the efficacy and safety of sodium salvianolic acid A for injection in myocardial protection in patients with acute myocardial infarction after PCI

Start Date04 May 2022

Sponsor / Collaborator

Chia Tai Qingchunbao Pharmaceutical Co., Ltd.

[+1]

CTR20210544 / CompletedPhase 2IIT

一项评价丹酚酸A片治疗糖尿病周围神经病变疗效和安全性的多中心、随机、双盲、安慰剂对照的II期临床试验方案

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of salvianolic acid A tablets in the treatment of diabetic peripheral neuropathy

丹酚酸A片II期临床研究采用多中心、随机、双盲、安慰剂对照的试验方法，初步评估不同剂量丹酚酸A片对糖尿病周围神经病变患者的治疗作用和安全性，观察病人的受益/风险比，确定有效剂量，为丹酚酸A片III期临床试验研究设计和给药剂量方案的确定提供科学依据。

[Translation]

The Phase II clinical study of Salvianolic Acid A Tablets adopted a multicenter, randomized, double-blind, placebo-controlled trial method to preliminarily evaluate the therapeutic effect and safety of different doses of Salvianolic Acid A Tablets on patients with diabetic peripheral neuropathy, observe the benefit/risk ratio of patients, determine the effective dose, and provide a scientific basis for the design of the Phase III clinical trial of Salvianolic Acid A Tablets and the determination of the dosage regimen.

Start Date11 May 2021

Sponsor / Collaborator

Institute of Materia Medica

100 Clinical Results associated with Salvianolic acid A

100 Translational Medicine associated with Salvianolic acid A

100 Patents (Medical) associated with Salvianolic acid A

676

Literatures (Medical) associated with Salvianolic acid A

01 Feb 2025·Talanta

Carrier-free immobilized enzyme for ligand fishing of carbonic anhydrase inhibitors in Salvia miltiorrhiza

Article

Author: Jia, Xiaozhuan ; Fan, Xiaohui ; Yang, Zhenzhong

The traditional method for natural products discovering could be time-consuming and labor-intensive, thus ligand fishing has attracted a lot of attention as a fast-screening method. Nevertheless, ligand fishing often relied on immobilized enzyme with solid carriers, which can be expensive and complicated to prepare. In this study, a carrier-free enzyme immobilization technology, cross-linked enzyme aggregates (CLEAs), was introduced by preparing carbonic anhydrase cross-linked enzyme aggregates (CA-CLEAs), aiming to develop a method for ligand fishing that is simpler, faster and more cost-effective. CA-CLEAs were synthesized with optimal conditions, and were proven to have the ability to capture CA inhibitors and recycle. The crude extract of Salvia miltiorrhiza (SM) was determined to have inhibitory activity against CA, and two major components of SM, i.e., phenolic acids and diterpenoids, were prepared and incubated with CA-CLEAs, respectively. Seven potential inhibitors were fished out and identified using liquid chromatography-mass spectrometry (LC-MS), and all of them were verified to have inhibitory activity, with two novel inhibitors, salvianolic acid C and tanshinone IIA, being discovered. Molecular docking simulations revealed the different inhibitory mechanisms of phenolic acids and diterpenoids. Furthermore, combination effect analysis was carried out, and the synergistic effects were discovered between two components, as well as between their representative compounds, i.e., salvianolic acid B and tanshinone IIA. In this study, a ligand fishing method based on carrier-free immobilized enzyme was established and applied to discover CA inhibitors. A variety of inhibitors with different inhibitory mechanisms were identified successfully, which could accelerate the development of CA inhibitors, demonstrating the efficiency and potential of the method in new bioactive compounds discovery.

01 Dec 2024·Phytomedicine

A stepwise integrated strategy to explore quality markers of Qishen Yiqi dripping pills against myocardial ischemia

Article

Author: Tang, Meng ; Zhou, Pei-Pei ; Xue, Lian-Ping ; Liu, Li-Wei ; Jia, Qing-Quan ; Sun, Zhi ; Zuo, Li-Hua ; Zhang, Zhi-Bo ; Zhao, Ling-Guo

BACKGROUNDNumerous experiments and clinical practices have demonstrated the effectiveness of Qishen Yiqi dripping pills (QSYQ) on myocardial ischemia (MI). However, the bioactive ingredients and mechanisms remain unclear, leading to huge gaps between quality control and biological effect of QSYQ. Discovering quality markers (Q-markers) based on effective components is crucial for ensuring stable quality and clinical effectiveness of QSYQ.PURPOSETo explore Q-markers of QSYQ against MI by a stepwise strategy integrating serum pharmacochemistry, network pharmacology, metabolomics, quantitative analysis, and cell experiments.METHODSFirstly, liquid/gas chromatography-mass spectrometry was applied to characterize chemical profiles of QSYQ in vitro and in vivo. Based on the serum migrating constituents, a component-target-MI interaction network was constructed. Subsequently, pharmacodynamics and metabolomics were conducted to evaluate cardioprotective effect and potential mechanism of QSYQ. Next, conjoint analysis of network pharmacology and metabolomics was performed to screen candidate Q-markers. Finally, the measurability and bioactivity were validated to justify their usage as Q-markers.RESULTSA total of 97 components were identified in QSYQ, 24 prototypes of which were detected in serum. The "component-target-disease" interaction network was constructed based on serum migrating constituents. Pharmacodynamic results showed that QSYQ effectively improved cardiac function, attenuated inflammatory cell infiltration, alleviated myocardial fibrosis, and reduced the levels of myocardial enzymes and oxidative stress in MI rats. Metabolomics study demonstrated that 59 metabolites were markedly altered in MI rats, 25 of which were significantly reversely regulated by QSYQ. After integrative analysis of network pharmacology and metabolomics, 12 components were selected as candidate Q-markers of QSYQ, and the contents were quantified. These candidate Q-markers displayed synergistic protective effects against H₂O₂-induced injury in H9c2 cells. Taken together, 12 components with properties of transitivity and traceability, effectiveness, measurability, and compatibility contribution were defined as representative Q-markers of QSYQ, including Astragaloside IV, Ononin, Calycosin, Formononetin, Rosmarinic acid, Cryptotanshinone, Salvianolic acid A, Tanshinol, Ginsenoside Rb1, Ginsenoside Rg1, Nerolidol, and Santalol.CONCLUSIONIn this study, a novel stepwise integrated strategy was presented for discovering Q-markers related to therapeutic effects of traditional Chinese medicine prescriptions. Twelve comprehensive and representative Q-markers of QSYQ were identified for the first time to improve its quality control.

01 Nov 2024·Saudi Pharmaceutical Journal

Identification of compounds from Origanum compactum and Origanum elongatum using HPLC/UV-ESI-MS and comparative analysis of their antioxidant, antimicrobial, anticoagulant, and antidiabetic properties

Article

Author: Al Kamaly, Omkulthom ; Drioiche, Aziz ; Alsfouk, Bshra A ; Zair, Touriya ; Saidi, Soukaina ; Remok, Firdaous ; Alsfouk, Bshra A. ; El Makhoukhi, Fadoua ; El Imache, Ahde

The aim was to assess the phytochemical composition, phenolic component levels, and biological properties of the flowering tops of Origanum compactum and Origanum elongatum. The study employed phytochemical assays, spectrophotometric techniques for quantitative analysis of polyphenols, flavonoids, and tannins, and compound identification using HPLC/UV-ESI-MS. The antimicrobial, antioxidant, anticoagulant, and antidiabetic properties were examined both in vitro and in vivo. The results showed that the O. compactum extract had significantly high levels of total polyphenols, measuring 47.368 mg gallic acid equivalents per gram, and flavonoids, measuring 14.839 mg quercetin equivalents per gram. The phytochemical examination of O. compactum revealed that lithospermic acid accounted for 36.82 % of the chemicals detected, followed by salvianolic acid C at 12.57 % and ros-marinic acid at 6.01 %. The main constituents of O. elongatum are salvianolic acid C (14.46 %), luteolin-3-O-glucuronide (13.51 %), salvianolic acid B (12.24 %), rosmarinic acid (7.83 %), and rutin (6.18 %). The results demonstrated different levels of effectiveness against the investigated microorganisms, with the extract from O. compactum exhibiting better activity, particularly against Gram-negative bacteria, certain yeasts, and the fungus Aspergillus niger. The aqueous extracts of both Origanum species demonstrate significant antioxidant activity. O. compactum has a higher total antioxidant capacity (IC₅₀ of 35.083 μg/mL) compared to O. elongatum (IC₅₀ of 77.080 μg/mL). However, O. elongatum has a higher reducing power (35.697 μg/mL) compared to O. compactum (42.563 μg/mL). In vivo evaluations revealed that the aqueous extracts of O. compactum and O. elongatum possess significant antihyperglycemic and anticoagulant properties. The extracts demonstrated a marked reduction in blood glucose levels during the oral glucose tolerance test (OGTT) in Wistar rats and effectively prolonged both prothrombin time (PT) and activated partial thromboplastin time (aPTT), highlighting their ability to inhibit coagulation pathways. Moreover, their comparable efficacy to standard antihyperglycemic medications and absence of severe toxicity, even at high doses, underscore their therapeutic potential for safe and effective treatment applications. Between the two species, O. compactum exhibited superior efficacy in key biological activities such as antioxidant, antimicrobial, and anticoagulant properties, making it a strong candidate for therapeutic applications. This study underscores the value of Origanum species as a rich source of bioactive compounds, offering significant potential in pharmaceuticals, nutraceuticals, and agri-food industries. The findings pave the way for further exploration of their diverse applications.

100 Deals associated with Salvianolic acid A

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathy	Phase 2	CN	Institute of Materia Medica	11 May 2021
Acute Chest Syndrome	Phase 1	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	21 Jul 2022
Diabetic Nephropathies	Phase 1	-	Chinese Academy of Medical Sciences	-
Peripheral Nervous System Diseases	Phase 1	-	Chinese Academy of Medical Sciences	-
Diabetic peripheral neuropathy	Discovery	CN	Chinese Academy of Medical Sciences	11 May 2021
Angina Pectoris	Discovery	CN	Beijing Bencao Tianyuan Medicine Research Institute	29 Nov 2018
Angina Pectoris	Discovery	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	29 Nov 2018
Angina Pectoris	Discovery	CN	Chia Tai Qingchunbao Pharmaceutical Co., Ltd.	29 Nov 2018
Coronary Artery Disease	Discovery	CN	Beijing Bencao Tianyuan Medicine Research Institute	29 Nov 2018
Coronary Artery Disease	Discovery	CN	Chia Tai Qingchunbao Pharmaceutical Co., Ltd.	29 Nov 2018

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