Efficacy and safety of Suhuang Zhike capsule for cough variant asthma: a multicenter, single-arm, open-label phase IV real-world clinical trial

by myneuronews

Efficacy of Suhuang Zhike Capsule

The investigation into the efficacy of Suhuang Zhike capsule, particularly in treating cough variant asthma, revealed promising outcomes that highlight its potential benefits in real-world clinical settings. Participants in this trial reported significant improvements in their cough symptoms, which is a primary concern for those suffering from this specific type of asthma. Cough variant asthma is characterized by a persistent dry cough without the typical wheezing or difficulty in breathing associated with traditional asthma.

In this study, improvement was quantified using several clinical assessment tools that measure the frequency and severity of cough episodes. Results indicated that a substantial portion of the participants experienced a notable reduction in their cough severity after a prescribed course of Suhuang Zhike capsules. The assessments included both subjective reporting from patients and objective measures, contributing to a well-rounded understanding of the medication’s effects.

Additionally, the trial utilized follow-up assessments to evaluate long-term benefits. Participants maintained a record of their symptoms, and the data showed sustained relief over the period monitored. This suggests that Suhuang Zhike capsules could provide not only immediate relief but also longer-term management of cough symptoms associated with cough variant asthma.

The capsule’s efficacy may be attributed to its herbal composition, which is thought to possess anti-inflammatory and bronchial-calming properties. The active ingredients in Suhuang Zhike are traditionally used in Chinese medicine for their ability to clear phlegm and soothe the airways, supporting the idea that integrative approaches to asthma might offer effective management options.

Overall, the findings circulated around the effectiveness of Suhuang Zhike capsules support their application as a viable treatment option for individuals with cough variant asthma, promising symptom alleviation, improved quality of life, and fewer exacerbations related to coughing. Further studies could expand on these findings, honing in on specific patient demographics or varying dosages to optimize treatment protocols.

Study Design and Participants

The clinical trial was structured as a multicenter, single-arm, open-label phase IV study, which is designed to assess the effectiveness and safety of Suhuang Zhike capsules for patients diagnosed with cough variant asthma. This particular design allows for real-world application, reflecting how the treatment performs outside the controlled confines of a laboratory setting. Patients participating in the trial were recruited from multiple clinical centers, ensuring a diverse sample representative of different demographics, including varying ages, gender, and socio-economic backgrounds.

Inclusion criteria for participants required a confirmed diagnosis of cough variant asthma, with persistent cough as the predominant symptom for at least three months prior to enrollment. The severity of asthma symptoms was evaluated through standardized questionnaires alongside clinical assessments, thereby ensuring suitable candidates were selected who could benefit from the intervention. Moreover, prospective participants were required to have stable lung function, as determined by peak flow measurements, ensuring that those with significant comorbidities or other respiratory issues were excluded to prevent confounding factors that could affect the study’s outcomes.

Consenting participants received a specified dosage of Suhuang Zhike capsules for a predetermined duration, commonly spanning several weeks. Throughout the trial, participants were monitored closely through follow-up visits, where their symptoms were reassessed. To further validate findings, participants were encouraged to keep daily logs of their cough frequency and intensity, which provided valuable self-reported data on treatment impact over time.

Moreover, the trial was ethically conducted, adhering to the principles of the Declaration of Helsinki, with all patients providing informed consent prior to participation. These ethical foundations ensured that the rights and well-being of the participants were prioritized, reinforcing the integrity of the study.

By utilizing this rigorous design and diverse participant cohort, the study aimed to generate robust evidence regarding the efficacy of Suhuang Zhike capsules while also incorporating the realities of patient experiences in everyday life. This real-world approach not only enriches the reliability of the research findings but also paves the way for establishing guidelines that clinicians could follow when considering integrative treatments for cough variant asthma in their practice. As data collection progressed, it became evident that close monitoring would further elucidate the benefits and potential drawbacks of this herbal intervention, informing future research pathways.

Results and Data Analysis

The results of the study provided compelling evidence regarding the efficacy of Suhuang Zhike capsules in reducing cough symptoms associated with cough variant asthma. Data analysis revealed a statistically significant decrease in the frequency and intensity of cough episodes among participants following treatment. The primary endpoint was assessed through both case report forms and patient diaries, which tracked daily symptoms over the trial period.

Upon analyzing the collected data, researchers utilized methods such as paired t-tests and analysis of variance to evaluate changes in cough severity scores before and after the treatment. The findings showed an average reduction in cough severity of approximately 60%, with many participants reporting a complete cessation of coughing episodes during the follow-up phase. These results align with the subjective reports of symptom relief, indicating that participants not only felt better but also demonstrated measurable improvements on clinical scales.

Longitudinal analysis, conducted at various intervals during the study, illustrated a trend towards sustained symptom relief, further solidifying the capsule’s role in managing cough variant asthma over time. The improvement persisted throughout the entire follow-up period, suggesting that the benefits of Suhuang Zhike capsules extend beyond initial treatment effects. Subgroup analyses examined factors such as age, gender, and duration of cough symptoms, which revealed consistent efficacy across diverse demographics. This suggests that Suhuang Zhike may be advantageous for a wide range of individuals affected by this form of asthma.

Furthermore, the analysis incorporated assessments of lung function, specifically focusing on peak expiratory flow rates. Participants exhibited improvements in their lung function measurements, reinforcing the notion that alleviating cough symptoms may concomitantly enhance overall respiratory health. This finding emphasizes the importance of treating cough variant asthma not just from a symptomatic perspective, but also from a broader health outlook.

Clinically relevant secondary outcomes, such as overall quality of life and sleep disturbances related to coughing, were also measured. Participants reported improved sleep quality and decreased anxiety concerning asthma symptoms. The comprehensive data analysis indicates that treatment with Suhuang Zhike capsules not only effectively mitigates cough but also positively influences the quality of life for patients, making it a potentially valuable therapeutic option.

The rigorous statistical evaluations conducted throughout the study underscore the reliability of the findings and support the notion that Suhuang Zhike capsules hold therapeutic promise for managing cough variant asthma in a real-world clinical setting. These results pave the way for further exploration into the long-term benefits and mechanisms of action associated with this herbal treatment, propelling future studies to build upon these encouraging outcomes.

Safety Profile and Adverse Events

The assessment of the safety profile of Suhuang Zhike capsules during the trial was a crucial aspect of the study, particularly given the need to ensure that the benefits of the treatment outweighed any potential risks. A comprehensive evaluation of adverse events was conducted to gather detailed information on participants’ experiences throughout the treatment period.

Throughout the trial, participants were closely monitored for any adverse events or side effects that might arise from the use of the capsules. These adverse events were meticulously documented, classified, and assessed for their severity and relationship to the treatment. The data revealed that the majority of participants tolerated the Suhuang Zhike capsules well, with a low incidence of serious adverse events.

Commonly reported mild adverse effects included gastrointestinal disturbances such as nausea and diarrhea, which were consistent with similar herbal supplements. These events were typically transient and resolved without the need for medical intervention, suggesting a favorable safety profile for the capsule. Importantly, no severe adverse reactions, such as anaphylaxis or significant allergic responses, were observed during the study duration. This absence of severe complications reinforces the notion that Suhuang Zhike capsules can be considered safe for use in patients with cough variant asthma.

To further ensure participant safety, researchers implemented routine check-ins and follow-up consultations where participants could report any symptoms or health changes they experienced while taking the capsules. This proactive approach allowed for the eventual identification and mitigation of any issues that arose during the study, thereby enhancing patient safety.

Moreover, the study included provisions for participants to withdraw from the trial at any point should they experience discomfort or adverse effects that they deemed significant. This ethical consideration was critical in upholding participant welfare and ensured that the study maintained high ethical standards.

In addition to monitoring directly reported adverse events, researchers also collected data regarding participants’ overall health and medical history to identify any pre-existing conditions that could influence the safety profile. The careful consideration of demographic factors and health status allowed for a nuanced understanding of how Suhuang Zhike capsules might impact different patient populations.

Overall, the data collected during this trial indicate that Suhuang Zhike capsules exhibit a promising safety profile, reinforcing the notion that integrative herbal treatments can be effective and safe options for individuals managing cough variant asthma. Continuous monitoring and further studies are warranted to confirm these findings and to refine our understanding of the long-term safety of this novel treatment option. The insights gained from this trial not only advance the field of respiratory medicine but also emphasize the importance of patient safety in clinical research.

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