1 Introduction

Astragalus membranaceus (Huangqi) is a foundation herb of traditional Chinese medicine (TCM), employed more than two millennia ago to "tonify qi," bolster the immune system, and enhance resistance to disease (Wang et al., 2019). It is an archetypal herb in traditional formulas for fatigue, chronic disease, and states of deficiency. In practice today, A. membranaceus is found in numerous decoctions, granules, and injections, a testament to its versatility in prevention and treatment.

The principal bioactive molecules of A. membranaceus are polysaccharides, saponins (specifically astragalosides), and flavonoids. Polysaccharides exhibit immunomodulatory and antioxidant activities, and enhance macrophage function as well as cytokine synthesis. Saponins possess anti-inflammatory, cardioprotective, and antiviral activities, while flavonoids are attributed to antioxidant activity and protection of cells. All these molecules are responsible for the extensive pharmacological action of A. membranaceus, rendering it of clinical value in multiple organ systems (Nguyen et al., 2024).

Respiratory diseases, including acute respiratory tract infection, bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), asthma, and pulmonary fibrosis, are severe global health burdens. A. membranaceus was found to have the capacity to inhibit inflammation, enhance immune response, and repress oxidative stress in these conditions. Its combination with standard therapies has been shown to add benefit to clinical endpoints like symptom palliation, lung function, and quality of life and is a useful adjunctive or complementary treatment in respiratory medicine (D'Avino et al., 2023).

This study systematically distills clinical evidence of A. membranaceus use in acute and chronic respiratory disease. It evaluates pharmacological mechanisms, therapeutic effects, safety profiles, and dosing regimens, with the goal of constructing a definitive portrait of its clinical usefulness. By synthesis of modern research, we seek to inform evidence-based practice, facilitate standardized use, and guide future clinical and pharmacological research in respiratory medicine.

2 Pharmacological Basis and Mechanisms of Astragalus

2.1 Anti-inflammatory and immunomodulatory effects

Astragalus membranaceus and its major bioactive compounds, such as astragaloside IV and polysaccharides, exert potent anti-inflammatory and immunomodulatory effects in respiratory disorders. They suppress inflammatory cell infiltration and inhibit the production of pro-inflammatory cytokines such as TNF-α, IL-6, and IL-1β. Astragaloside IV can suppress NF-κB pathway activation, decrease Th2 cytokines, and affect transcription factors such as STAT6 and RORγt to alleviate airway remodeling and inflammation in asthma. The Astragalus polysaccharides also decrease lung fibrosis and damage by suppressing the TLR4/NF-κB pathway and affecting the balance of Treg/Th17 cells involved in immune homeostasis in asthma and other respiratory disorders (D'Avino et al., 2023) (Figure 1). Besides, Astragalus may control the gut-lung axis by enhancing the composition of gut microbiota, which in turn is responsible for its immunoregulatory impacts on pulmonary pathology (Shen et al., 2019; Wang et al., 2019; Yang and Wang, 2019; Wei et al., 2023).

Figure 1 Astragalus extracts in the inhibition of allergic and non-allergic inflammation (Adopted from D’Avino et al., 2023)

2.2 Antioxidant and anti-apoptotic activities

Astragalus and its components possess potent antioxidant activity, which is essential for protective effects of lung tissue against oxidative stress-induced damage. Astragaloside IV reduces the indicators of oxidative stress, replenishes glutathione levels, and decreases iron levels in lung tissue and hence inhibits ferroptosis, a form of cell death involved in respiratory injury. All these activities are mediated through Nrf2/SLC7A11/GPX4 pathway activation, augmenting cellular antioxidant function. Moreover, Astragalus polysaccharides can inhibit lung tissue apoptosis by regulating key signaling pathways and increasing the redox capacity of cells, inhibiting further pulmonary fibrosis tissue damage in pulmonary fibrosis models and particulate matter-induced lung injury models (Wu et al., 2020; Wang et al., 2022).

2.3 Anti-fibrotic and anti-tumor mechanisms

Astragalus has potent anti-fibrotic effects against several genes and pathways involved in pulmonary fibrosis, such as VCAM1, RELA, and JUN. Its bioactive ingredients inhibit collagen synthesis, extracellular matrix deposition, and epithelial-mesenchymal transition that are responsible for fibrosis development. Astragaloside IV also promotes autophagy by the Ras/Raf/MEK/ERK pathway to inhibit aberrant collagen synthesis and promote lung function. In addition, astragalosides and analogs exhibited anti-cancer activities in lung cancer models by suppressing the PI3K/Akt and HIF-1 signaling pathways and hitting targets such as STAT3 and AKT1, showing a potential therapeutic use to the prevention and adjunctive therapy of lung cancers (Bing et al., 2022; Yu et al., 2022; Ding et al., 2025).

2.4 Regulation of respiratory system-related signaling pathways

Astragalus and active ingredients regulate several important signaling pathways related to respiratory disease. These include inhibition of the TLR4/NF-κB/MyD88 signal pathway, decreasing inflammation and oxidative damage, regulation of the PI3K/Akt/mTOR signal pathway, restoring autophagic flux and reduction of lung damage. The Nrf2/SLC7A11/GPX4 signal pathway is triggered to suppress ferroptosis and oxidative injury, and the Ras/Raf/MEK/ERK pathway is associated with the induction of autophagy and anti-fibrosis. Moreover, Astragalus modulates the JAK2/STAT6 and HMGB1/RAGE/NF-κB pathways and restrains airway inflammation and remodeling in asthma. Through these multi-target and multi-pathway mechanisms, Astragalus evokes extensive protective effects on many respiratory diseases (Pei et al., 2021; Wang et al., 2022; Yu et al., 2022; Wei et al., 2023).

3 Clinical Applications of Astragalus in Acute Respiratory Diseases

3.1 Acute upper respiratory tract infections

Astragalus membranaceus has been traditionally long used in preventing and treating acute upper respiratory tract infection (URTIs), particularly in Chinese traditional medicine. Recent pharmacological studies have demonstrated that Astragalus polysaccharides can activate innate immunity by inducing expression of antimicrobial peptides such as LL-37 in respiratory epithelial cells and thereby having direct anti-infective activity. Its immunomodulatory activity is mediated through activation of p38 MAPK, JNK, and NF-κB signaling pathways that play central roles in host defense against infection. These findings offer a rationale for the therapeutic use of Astragalus in the prevention and treatment of acute URTIs. However, systematic reviews of randomized controlled trials revealed no adequate evidence of high quality to prove the efficacy and safety of oral Astragalus alone as an intervention for the prevention of recurrent episodes of acute respiratory tract infections in children, calling for more rigorous clinical trials (Su et al., 2016; Zhao et al., 2018).

3.2 Acute bronchitis

Immunomodulatory and anti-inflammatory actions of Astragalus membranaceus suggest potential therapeutic advantages in the treatment of acute bronchitis. Astragalus saponins and polysaccharides are able to inhibit pro-inflammatory cytokine gene expression and airway inflammation, the two primary pathological features of acute bronchitis. At the same time, Astragalus is capable of modulating immune response and inducing mucosal repair to achieve symptom relief and earlier recovery. Whereas preclinical and mechanistic studies substantiate these activities, there is no strong direct clinical evidence to support the use of Astragalus in acute bronchitis, and good clinical trials would be required to establish its safety and efficacy in this indication (Chen et al., 2020; Tan et al., 2023).

3.3 Community-acquired pneumonia

Astragalus membranaceus has been explored as an adjuvant therapy in community-acquired pneumonia due to its immunostimulatory, anti-inflammatory, and antioxidant properties. Bioactive molecules in it are able to modulate immune cell function, stimulate the clearance of pathogens, and inhibit over-inflammation-induced lung injury. Some clinical trials and reviews of literature report that Astragalus-containing products may improve clinical outcome, reduce the severity of symptoms, and reduce complications in patients with pneumonia. However, the evidence currently available is based primarily on studies on more inclusive respiratory infections or traditional Chinese medicine formulations, and no high-quality large-scale randomized controlled trials targeting community-acquired pneumonia are present. Accordingly, while Astragalus is presented positively as adjunctive therapy, more robust clinical trials need to be conducted to define its role in the management of community-acquired pneumonia (Law et al., 2020; Zheng et al., 2020).

4 Clinical Applications of Astragalus in Chronic Respiratory Diseases

4.1 Chronic obstructive pulmonary disease (COPD)

Astragalus membranaceus and its bioactive molecules, astragalosides, and polysaccharides have been documented to have therapeutic potential in COPD by anti-inflammatory, antioxidant, and immunomodulatory effects. Cigarette smoke- and particulate matter-induced models of COPD in animals show that Astragalus polysaccharides can promote alveolar macrophage phagocytic activity, suppress pro-inflammatory cytokine IL-6, IL-8, and TNF-α levels, and reverse lung injury. Astragaloside II can relieve lung injury and histopathological damage by being involved in the process of the mTORC1/GSK-3β pathway suppressing NF-κB-induced inflammation. These findings suggest that Astragalus and its active constituents are powerful adjuncts for the management of COPD via inhibiting inflammation and enhancing lung function, though more clinical trials are required to prove such benefits among human patients (Chu et al., 2016; Tan et al., 2023; Chen et al., 2024).

4.2 Bronchial asthma

Astragalus membranaceus is most well known for its anti-asthmatic effect, which is explained by its immune response modulating and down-regulating action on airway inflammation. Experimental and clinical data indicate that Astragalus extracts standardized on the content of polysaccharides are able to inhibit the release of pro-inflammatory mediators, decrease airway hyperresponsiveness, and suppress airway remodeling and fibrosis. Astragaloside IV, the principal saponin, was found to modulate Th2 immune responses, decrease IgE levels, and inhibit sensitization in asthmatic allergy models. Astragalus, in combination with standard treatment, improved lung function and modulated the Treg/Th17 cell ratio in children with remitted asthma, reaffirming its application as an adjunctive treatment in asthma (Wang et al., 2019; D'Avino et al., 2023; Yuan et al., 2023).

4.3 Interstitial lung diseases

Astragalus membranaceus's anti-inflammatory and anti-fibrotic effects make it a potential candidate drug for interstitial lung disease. Its bioactive compounds can modulate immune cell function, suppress the secretion of pro-inflammatory cytokines, and inhibit the formation of tissue fibrosis. Research studies in network pharmacology have identified some targets and pathways on which Astragalus polysaccharides exerts its effects, such as regulating genes VCAM1, RELA, and JUN. These polytarget therapies have the ability to slow the progression of interstitial lung disease and improve clinical outcomes, though additional focused clinical trials will be required (Bing et al., 2022; Zhu et al., 2022).

4.4 Pulmonary fibrosis

Astragalus membranaceus showed significant anti-fibrotic effects in preclinical and clinical studies of pulmonary fibrosis. Astragalus polysaccharides act on various pathways and mechanisms, regulating the expression of genes involved in fibrosis development, and inhibiting collagen deposition and extracellular matrix formation (Sun et al., 2024) (Figure 2). Systematic reviews and meta-analyses indicate that Astragalus, when used alone or in combination with other herbal medicines, has the potential to improve pulmonary function, exercise tolerance, and quality of life in idiopathic pulmonary fibrosis patients, with an acceptable safety profile. These findings offer evidence to substantiate the use of Astragalus in pulmonary fibrosis as an effective and safe adjunctive therapy, for which large-scale, high-quality randomized controlled trials are still needed to continue building the evidence base (Zhang et al., 2020; Bing et al., 2022; Gong et al., 2022).

Figure 2 Mechanistic insights into the inhibitory effects of Astragalus membranaceus on pulmonary fibrosis (Adopted from Sun et al., 2024)

5 Studies on Astragalus Formulations and Combination Therapies

5.1 Use in classic traditional Chinese medicine formulas

Astragalus membranaceus is one of the fundamental herbs in most classical prescriptions in traditional Chinese medicine (TCM) for preventing and treating respiratory and fibrotic diseases, such as Yupingfeng San and Bu Zhong Yi Qi Tang. Astragalus is often combined with other herbs, i.e., Angelica sinensis and Salvia miltiorrhiza, for enhanced therapeutic activity, particularly in chronic respiratory and fibrotic diseases. Astragalus combined with Angelica sinensis has, for example, been found to have greater therapeutic effect in experimental idiopathic pulmonary fibrosis models than either individually, through mechanisms including autophagy induction and suppression of the mTOR signaling pathway. These synergistic effect-based polyherbal preparations, targeting a range of pathological processes including inflammation, oxidative stress, and tissue remodeling, form a mainstay of TCM clinical practice in respiratory medicine (Zhu et al., 2022; Sun et al., 2024).

5.2 Clinical studies combining Astragalus with Western medicines for respiratory disorders

A number of clinical trials and meta-analyses are evaluating the efficacy of Astragalus-based Chinese herbal medicine in addition to Western treatment for respiratory disease, especially in oncology and chronic lung disease. In non-small-cell lung cancer, addition of Astragalus-based TCM to platinum-based chemotherapy improves overall survival, tumor response rates and performance status, and reduces the incidence of chemotherapy-induced adverse effects. Subgroup analysis indicates that individualized herbal decoctions based on syndrome differentiation are superior to standardized preparations given orally or through injection. Similarly, in chronic obstructive pulmonary disease (COPD), the combination of Astragalus injection with ambroxol hydrochloride as adjuvant therapy has been shown to increase clinical efficacy, lung function, and blood gas analysis compared to routine treatment. These findings supplement the pairing of Astragalus with Western medicine for enhancing therapeutic effects and reducing toxicity in respiratory illness (Wang et al., 2016; Zhou et al., 2023).

5.3 Applications of Astragalus injections and modern formulations

These Astragalus development into contemporary drug form such as injections and granules are intended for improving bioavailability and clinical convenience. Astragalus injection is now standardized drugs in China used as adjjuvant treatment of respiratory and cardiovascular disease, and the use of the combination with traditional medicine has been proved to be superior in efficacy and safety. For example, Astragalus injection of ambroxol hydrochloride in patients with COPD induces dramatic arterial blood gas and lung function improvements. Furthermore, novel delivery systems such as spatiotemporal pellets, which combine Astragalus with other herbal components, are being explored to enhance release and absorption of active ingredients, yet further boosting therapeutic efficacy. These new formulants represent an important milestone towards the therapeutic application of Astragalus in respiratory diseases (Zhu et al., 2022; Zhou et al., 2023; Sun et al., 2024; Zhang et al., 2024).

6 Clinical Evidence and Efficacy Evaluation

6.1 Results from randomized controlled trials and systematic reviews

Systematic reviews and randomised controlled trials (RCTs) are the gold standard for determining the efficacy of intervention, for example, Astragalus membranaceus in respiratory illness. RCTs provide greater internal validity through measurement of the effect of Astragalus under controlled conditions, while systematic reviews aggregate the evidence from many studies to conduct a comprehensive efficacy and safety assessment. However, in even conventional Chinese medicine and herbal treatment environments, heterogeneity problems with study design, patient populations, and outcomes measures typically limit the quality of the findings. Emerging methodological advances facilitate the synthesis of RWE and RCT evidence to capture effectiveness more precisely in more representative clinical practice, especially in the case of multi-component interventions like Astragalus-based treatments (De Lusignan et al., 2015; Selker et al., 2019; Yuan, 2021; Zhuang et al., 2023).

6.2 Assessment of efficacy and safety

Efficacy studies of Astragalus in respiratory illness are founded on RCTs as well as real-world data. RCTs demonstrate that Astragalus can add to clinical efficacy such as relief of symptoms, lung function, and health-related quality of life in several diseases of the respiratory tract. Safety profiles are generally good with most trials showing mild or no side effects. However, external validity of RCTs is limited by rigorous inclusion criteria, and more and more is being used in real-world research to determine safety and efficacy in generalizable populations. Robust assessment frameworks now support the combination of evidence from RCTs, systematic reviews, and RWE to provide an overarching view of efficacy and safety (De Lusignan et al., 2015; Blonde et al., 2018).

6.3 Analysis of dosage and treatment duration in clinical applications

Dosage and treatment duration analysis is required to enhance Astragalus' clinical use to the maximum. RCTs typically employ standardized doses and predetermined treatment durations, but it could be individualized in real practice based on patient profile and severity of disease. Modern reviews highlight the necessity for better reporting and analysis of dosage and duration in trials to provide guidance and reproducibility. Furthermore, personalized medicine approaches and adaptive clinical trial design are being explored to further individualize Astragalus therapy to a patient's needs, both based on traditional wisdom and modern clinical evidence (Yuan, 2021; Zhuang et al., 2023).

7 Research Challenges and Limitations

7.1 Limited scale and quality of clinical trials

Although Astragalus membranaceus is intensively studied for respiratory diseases, a majority of clinical trials are marred with low sample sizes, short intervention durations, and single-center studies. These compromise statistical power, increase the risk of bias, and restrict generalizability of the findings. In addition, variability in study protocols, inclusion criteria of the patient population, and measures of outcome makes it difficult to compare across studies and to perform meta-analyses (Wu et al., 2020; Ying et al., 2021).

7.2 Incomplete understanding of active component mechanisms

The major bioactive constituents of A. membranaceus, i.e., polysaccharides, saponins, and flavonoids, exhibit different pharmacological activities such as immunomodulation, anti-inflammation, and antioxidant activity. However, the distinct molecular mechanisms of these effects in respiratory diseases are not well understood. Complex relationships between complex components and targets, and variations in absorption and metabolism, pose significant challenges to mechanism explorations (Shen et al., 2019; Yang and Wang, 2019).

7.3 Limitations in standardized preparations and quality control

Clinical action of A. membranaceus can be very dissimilar depending on source, processing, and formulation (Selker et al., 2019; Zhuang et al., 2023). Decoctions, extracts, and injectables differ in the content of bioactive constituents and therefore have disparate effects. Different preparation protocols and details of quality control operations limit reproducibility and pose challenges for clinical application.

7.4 Insufficient translation between clinical and basic research

There is a disconnect between mechanistic research and clinical practice. While preclinical studies provide data regarding potential molecular mechanisms and pharmacologic effects, the findings are not always preceded by well-conceived clinical trials with appropriate endpoints. Improved integration of basic science and clinical study design will be necessary for validation of therapeutic mechanisms as well as treatment optimization.

8 Concluding Remarks

Astragalus membranaceus has been found to possess therapeutic significance in the treatment of acute and chronic respiratory infections including upper respiratory infections, bronchitis, pneumonia, COPD, asthma, and pulmonary fibrosis. The clinical evidence indicates that A. membranaceus either alone or in combination with traditional medicine has the ability to increase respiratory function, decrease inflammation, and improve immune function. Recent pharmacologic studies also revealed in greater detail mechanisms such as anti-inflammatory, antioxidant, immunomodulatory, and anti-fibrotic activity validating its therapeutic use scientifically.

Quality and reliability assurance of clinical evidence is a prerequisite to the application of A. membranaceus in evidence-based medicine. Reproducibility and efficacy can be guaranteed by standardization of products, meticulous trial design, standardization of outcomes measures, and proper reporting. Enhanced reinforcement of these variables will lead to high-quality clinical guidelines as well as safe and effective therapeutic application.

Future research should be aimed at large-scale, multicenter randomized controlled trials to determine clinical effectiveness and safety in different populations. Combination of modern pharmacological studies with clinical trials can provide further insights into molecular mechanisms, optimize dosage regimens, and result in the discovery of bioactive molecules with selective activities. These approaches will advance the scientific merit of A. membranaceus, enable its standard use in pulmonary medicine, and accelerate modernization of traditional Chinese medicine.

Acknowledgments

The authors sincerely thank the research team for their thoughtful assistance and strong support during the conduct of the study and the organization of materials. The authors also express their gratitude to the two anonymous reviewers for their valuable comments and constructive suggestions during the review process.

Conflict of Interest Disclosure

The authors affirm that this research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

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