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Therapeutics for Moderate and Severe Dengue

Dengue Severe Dengue Mosquito-Borne Diseases Vector Borne Diseases +4

The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.

Начало: 01.10.2026 Край: 31.07.2031 Възраст: от 5 г.

Bangladesh, Brazil, Colombia +7 Oxford University Clinical Research Unit, Vietnam NCT07543458

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Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Cardiac rehabilitation (CR) participation remains suboptimal, partly due to logistical challenges and limited access to center-based programs. Hybrid Endurance-Strength Training (HybEST) offers an alternative model by combining supervised endurance and strength exercises with home-based components. The main questions it aims to answer are: * Does a hybrid exercise program significantly improve a patient's body function and structures \[exercise capacity, body composition, and muscle strength\] compared to usual care? * Does a hybrid exercise program significantly improve a patient's activity \[functional capacity, physical activity, and total energy expenditure\] compared to usual care? * Does a hybrid exercise program significantly improve a patient's participation \[health-related quality of life\] compared to usual care? This single-center, two-arm parallel randomized clinical trial aims to evaluate the effects of HybEST on health-related outcomes and quality of life among patients with coronary artery disease in Phase II CR. Eligible participants will be randomly assigned in a 1:1 ratio to either the HybEST intervention group or the standard CR control group using a lottery method, specifically the sealed envelope approach. Assessments will be conducted at baseline (T0), Week 5 (T2), and Week 9 (T3) to measure changes in health-related outcomes and quality of life.

Начало: 01.10.2026 Край: 01.12.2027 Възраст: 18–75 г.

Malaysia University of Malaya NCT07130045

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Mindfulness-Based Substance Use Prevention (MINDS-UP)

Substance Use

The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The main questions it aims to answer are: 1. Is MINDS-UP feasible and what is its preliminary efficacy? 2. Are MRI protocol and procedures feasible? An additional exploratory question is: Are there neural and psychopathological mechanisms through which MINDS-UP might work? Researchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP. Participants will * take assessment #1 * have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start * take assessment #2 * take PPW, a single remote and research assistant-delivered 45-minute session * take assessment #3 * take assessment #4

Начало: 01.10.2026 Край: 01.01.2028 Възраст: 10–14 г.

New York State Psychiatric Institute NCT06593470

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Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

Cutaneous Metastatic Melanoma

This device phase I/II, first in human, early feasibility study (EFS), open-label, single-arm trial aims to evaluate the safety, tolerability, and preliminary efficacy of Gold Nanorod (GNR)-enabled sub-ablative targeted hyperthermia therapy (THT) in patients with unresectable stage 3C/3D/4M1 cutaneous metastatic malignant melanoma that have failed to respond to systemic checkpoint and localized intra-tumoral immunotherapy. The study will involve up to 10 participants with stable or progressive cutaneous and/or subcutaneous skin lesions (Immune Stable Disease (iSD) or Immune Confirmed/Unconfirmed Progressive Disease (iCPD/iUPD)). GNRs, when administered via intra-tumoral injection and activated by NIR light, generate localized heat through a process called THT. This approach selectively targets tumor cells while minimizing damage to surrounding healthy tissue. In this study, 10 participants will receive two THT treatments spaced 7 days apart. The primary objective of this study is to assess the safety and tolerability of THT treatment.

Начало: 01.10.2026 Край: 30.12.2026 Възраст: от 16 г.

Sona Nanotech Inc NCT06870994

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Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.

Odontectomy (Tooth Extraction) Socket Preservation and Healing Following Simple, Non-surgical Extraction Alveolar Bone Density and Postoperative Pain Management Periapical Radiolucency

This study evaluates the use of Concentrated Growth Factor (CGF) plugs-a third-generation healing material made from the patient's own blood-to improve recovery after simple tooth extractions. CGF contains a dense matrix of growth factors and regenerative cells designed to enhance wound healing and tissue regeneration. Participants requiring a single, non-surgical tooth extraction will have a CGF plug placed into the empty socket immediately following the procedure. The researchers will then monitor two main factors: * Post-operative Pain: Patients will record their pain levels on a scale of 0 to 10 at 1, 3, and 7 days after the extraction. * Bone Density: Using specialized imaging (CBCT), the researchers will measure how well the bone heals and fills the socket immediately after the procedure and again at 3 months. The goal of this research is to determine if CGF plugs can effectively reduce patient discomfort and help preserve bone density, which is critical for future dental treatments like implants.

Начало: 28.09.2026 Край: 30.12.2026 Възраст: 20–50 г.

Egypt Cairo University NCT07542795

Предстои набиране Фаза 2

Nirogacestat in Patients With Kaposi Sarcoma

AIDS-Related Kaposi Sarcoma Skin Kaposi Sarcoma

This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.

Начало: 17.09.2026 Край: 17.02.2030 Възраст: от 18 г.

United States AIDS Malignancy Consortium NCT07539454

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Evaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease

Peripheral Arterial Disease

Peripheral artery disease (PAD) is a common atherosclerotic condition characterized by reduced blood flow to the lower extremities, leading to intermittent claudication, decreased walking capacity, and impaired quality of life. Supervised exercise therapy is recommended as the first-line non-invasive treatment for patients with PAD; however, participation in center-based programs is often limited due to accessibility, time constraints, and symptom-related barriers. This randomized controlled study aims to evaluate the clinical effectiveness of a hybrid cardiac rehabilitation program compared with conventional supervised exercise therapy in individuals diagnosed with peripheral artery disease. Participants will be randomly assigned to either a hybrid cardiac rehabilitation group or a supervised exercise therapy group. The hybrid cardiac rehabilitation program will combine center-based supervised exercise sessions with home-based telerehabilitation, supported by remote monitoring and wearable activity tracking devices. The supervised exercise therapy group will receive a fully center-based, physiotherapist-supervised exercise program. Both interventions will be delivered over a 12-week period. Primary outcomes will include walking performance and functional capacity. Secondary outcomes will assess exercise adherence, symptom severity, physical activity levels, and quality of life. The results of this study are expected to provide evidence on the feasibility and effectiveness of hybrid cardiac rehabilitation as an alternative rehabilitation model for patients with peripheral artery disease.

Начало: 16.09.2026 Край: 16.04.2027 Възраст: 50–70 г.

Turkey (Türkiye) Biruni University NCT07550959

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Precarity and Reduction of Its Impact on the Mental Health of Health Students

Mental Health (Depression) Mental Health Quality of Lifte

Student financial insecurity has become a major public health and societal issue affecting a growing proportion of young adults in higher education, exacerbated by the COVID-19 pandemic and more recently by inflation. Health students may be particularly exposed because of the demanding and lengthy nature of their training, often combined with limited opportunities for paid work due to hospital placements and academic workload. A national study conducted in 2024 by our team at Institut national de la santé et de la recherche médicale U1073 under the supervision of the Conférence Nationale des Doyens de Médecine among more than 12,000 health students showed that 12% experienced severe financial insecurity, characterized by insufficient monthly resources, recurrent bank overdrafts, and frequent food deprivation, while 20% reported moderate insecurity. Financial insecurity was strongly associated with anxiety, depression, and emotional exhaustion, while vulnerable students were also more likely to forgo healthcare, including psychological consultations, for financial reasons. This vicious circle between financial hardship and mental health may compromise academic success and justifies targeted intervention. Although support systems such as Santé Psy Étudiant and free psychological consultations at the faculty already exist, they remain underused because of stigma, insufficient information, or perceived barriers to access. The PRISMES project proposes a participatory, adaptive, and real-world intervention designed to improve mental health support for financially vulnerable health students. Students directly participate in the co-construction of interventions together with researchers, student associations, health professionals, academic representatives, and a sociologist involved in understanding social determinants, mental health representations, and barriers to participation. Three intervention formats will initially be proposed, Three types of interventions are offered to students. Intervention I consists of four individual psychological consultations. Intervention II includes two collective workshops focused on stress and budget management, combined with two sophrology sessions. Intervention III comprises one psychological consultation and two collective workshops on stress and budget management.. This non-randomized design reflects real-life implementation conditions and improves future transferability. The main objective is to provide concrete support to financially vulnerable students by improving well-being, mental health, and knowledge of available support systems. Secondary objectives are to evaluate intervention effects on anxiety, depression, stress, quality of life, and emotional exhaustion, to adapt interventions according to feedback, and to improve awareness and use of social and health support services. A mixed-method design will combine quantitative and qualitative data. Quantitative assessments will be conducted monthly during the three months following the first intervention and again three months after the final intervention. Validated questionnaires will assess perceived stress (Cohen scale), anxiety and depression (HAD score), quality of life, and emotional exhaustion (MBI-SS). Qualitative interviews and focus groups conducted at the end of the intervention will explore perceived benefits, barriers, and implementation factors among students and professionals. The adaptive design allows continuous adjustment according to interim findings. For example, if attendance is limited by timetable constraints, sessions may be rescheduled. Feedback loops involving participants and stakeholders will guide iterative improvement. Eligible participants are health students aged 18-30 enrolled at Université de Rouen Normandie presenting at least one indicator of financial insecurity: insufficient monthly resources, recurrent overdraft, or frequent food deprivation. Students currently receiving psychological follow-up are excluded. Assuming a reduction in anxiety prevalence from 55% to 45%, 88 participants are required; with 20% loss to follow-up, 110 students will be included. Among approximately 4,500 health students in Rouen, about 540 are estimated to experience severe insecurity and 900 moderate insecurity, ensuring strong feasibility. PRISMES aims to generate directly transferable recommendations for university support policies and improve resilience, well-being, and academic success.

Начало: 15.09.2026 Край: 30.09.2027 Възраст: 18–30 г.

France Institut National de la Santé Et de la Recherche Médica NCT07539207

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A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan

Infectious Diseases

The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan. Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate. This study is seeking for patients with: * sepsis (A very serious infection in your blood caused by germ (a bacteria)) or * renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time. Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.

Начало: 15.09.2026 Край: 30.03.2029

Pfizer NCT06864585

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ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves

Severe Aortic Valve Stenosis

Title: The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves Brief Summary: The goal of this clinical trial is to compare the latest-generation balloon-expandable (SAPIEN 3 Ultra Resilia) versus self-expanding (Evolut FX) transcatheter aortic valves in patients with severe, symptomatic aortic stenosis who are undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: Does device success rate (defined by VARC-3 criteria) at 30 days differ between the SAPIEN 3 Ultra Resilia and the Evolut FX valves? Do hemodynamic performance (mean gradient, effective orifice area) and incidence of moderate/severe paravalvular leak differ between the two valve types at 30 days and 1 year? Researchers will compare patients randomized to receive the SAPIEN 3 Ultra Resilia valve versus patients randomized to receive the Evolut FX valve to see if there are differences in device success, safety outcomes, and valve performance. Participants will: Undergo standard pre-procedural clinical, echocardiographic, and CT assessment Be randomly assigned to receive either the SAPIEN 3 Ultra Resilia or Evolut FX valve during their clinically indicated TAVI procedure Receive post-procedure follow-up assessments including echocardiography and clinical evaluation at 24 hours, 30 days, 6 months, and 1 year

Начало: 12.09.2026 Край: 12.12.2027 Възраст: от 18 г.

Egypt Assiut University NCT07545369

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Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study

Lymphatic Reconstruction Lymphadenectomy

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Начало: 06.09.2026 Край: 01.09.2028 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06887205

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Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation

Acne Vulgaris

This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Rising antibiotic resistance necessitates alternative therapeutic approaches. Emerging evidence highlights the gut-skin axis, suggesting probiotics may reduce systemic inflammation and acne severity. A total of 64 patients will be randomized into probiotic and placebo groups and treated for 12 weeks. The primary outcome is reduction in total acne lesion count, while the secondary outcome is change in serum Interleukin-6 levels. Clinical assessment includes lesion counts, GAGS scoring, and standardized photography. IL-6 levels will be measured using ELISA at baseline and study completion. Data will be analyzed using SPSS with appropriate statistical tests, considering p ≤ 0.05 as significant. This study aims to provide evidence for probiotics as a safe, effective, and antibiotic-sparing option in acne management, particularly in South Asian populations.

Начало: 01.09.2026 Край: 01.08.2027 Възраст: 15–35 г.

Pakistan Foundation University Islamabad NCT07539129

Предстои набиране Фаза 1

Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda

Malaria (Plasmodium Falciparum) Malaria Falciparum Malaria Infection Malaria Prophylaxis +3

This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants are protected from becoming ill with malaria whilst the MMV371 is still present in their body. The study will enroll approximately 80 healthy male and female participants, aged 12 to 50 years. Before starting the study participants will be given a standard approved course of artemether lumifantrine (AL) to clear any malaria infection they have. Once the AL course has been completed the study drug will be given by injection in the muscle of the upper arm, the side of the thigh, or the hip. Three out of four participants will receive MMV371 and 1 in four participants will receive placebo. Placebo is a dummy medicine. All participants have an equal chance of being assigned to receive the injection in the upper arm, outer thigh or hip. Neither the participants nor the researchers treating the participants will know who received MMV371 or placebo until after the study is completed. Key study features include: * Study duration for each participant: up to 7 months * MMV371 or placebo given: a single intramuscular (IM) injection * Visit schedule: Participants will remain in-clinic on Days -1-2 (2 overnight stays), followed by 15 follow-up visits: Day 4, then weekly for 1 month, and subsequently every 2 weeks until the End-of-Study (EoS) visit at Week 24. These frequent visits are necessary to monitor safety, the levels of MMV371 in the body, and to perform malaria detection testing until EoS (Week 24).

Начало: 01.09.2026 Край: 01.03.2028 Възраст: 12–50 г.

Rwanda Medicines for Malaria Venture NCT07548021

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A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL

LAL

To evaluate the benefit of a precision medicine based strategy (targeted therapeutic options (TTOs)) for patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) (in terms of composite remission).

Начало: 01.09.2026 Край: 01.03.2030 Възраст: 15–99 г.

Czechia, France, Germany +3 Philippe ROUSSELOT NCT07522801

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Transgender Analysis of Nephrological Studies Focused on Renal Metrics

Kidney Disease Kidney Injury Transgender Individuals

This study investigates how sex hormones affect kidney function in people undergoing gender-affirming hormone therapy (GAHT). We know men have a faster progression of kidney disease. Earlier studies suggest that the female sex hormone estradiol may have a protective effect on kidney function while the male sex hormone testosterone may have the opposite effect. But the reasons why this happens remain unclear. By studying participants undergoing (GAHT) we gain insight into the mechanisms by which testosterone and estradiol influence the kidneys. People undergoing GAHT provide a unique chance to study how sex hormones interact with the kidneys. The results may help us to understand why men and women exhibit differences in kidney disease development. This study will include 30 men and 30 women, aged 18 to 40, who start GAHT. Participants will have three study visits, two of which will happen during their scheduled healthcare appointments. During the first visit, a screening will take place to check if patients can take part in the study. At study visits before and after one year of therapy, kidney function is measured, kidney MRI is performed, urine is collected and a small sample of fat tissue. Taking part in the study does not delay the start of GAHT.

Начало: 01.09.2026 Край: 01.09.2028 Възраст: 18–40 г.

Netherlands Amsterdam UMC, location VUmc NCT07542964

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EFFECT OF ANIMATION-BASED DIGITAL EDUCATION ON RISK KNOWLEDGE AND FRAILTY IN OLDER ADULTS

Aging Frail Elderly Geriatric Syndromes

With the global aging trend, the management of geriatric risks faced by older adults and the effectiveness of health education for this population are gaining increasing importance. Literature indicates that health education for older adults, when delivered through methods that support individual engagement and the use of digital tools, yields more effective results in terms of learning and behavior change. This doctoral study aims to evaluate the effect of a digital education model, structured based on the Health Belief Model and developed using branching scenario animation technique, on geriatric risk knowledge level and frailty status among older adults residing in nursing homes. The study will be conducted as a randomized controlled trial in three nursing homes in Istanbul, with measurements at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3). Based on power analysis, 66 participants will be randomly assigned to intervention and control groups (33 per group) using block randomization. The intervention group will receive scenario-based digital animation education developed on the Vyond platform and structured according to the theoretical components of the Health Belief Model. The control group will receive standard care during the study period and will be offered the same digital animation education after completion of all assessments (post 3-month follow-up). The primary outcome is geriatric risk knowledge level, assessed using an interactive digital game called "Knowledge Wheel." Secondary outcomes include frailty status, measured by the Edmonton Frail Scale, and technology acceptance. Changes in knowledge and frailty levels measured through assessment tools will reveal the short- and medium-term effects of the education. Thus, the model's impact on health-related behavior change in older adults will be comprehensively evaluated. The unique aspect of this study is that it will be one of the first experimental studies to implement an interactive scenario-based digital education model in older adults. The findings are expected to contribute to the development of age-friendly health education models.

Начало: 01.09.2026 Край: 01.02.2027 Възраст: от 65 г.

Saglik Bilimleri Universitesi NCT07547358

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Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?

Multiple Sclerosis RRMS Multiple Sclerosis (MS) - Relapsing-remitting

The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI. While MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies. The primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up. A total of 136 patients with recent neurological exacerbations will be included. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES. This study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.

Начало: 01.09.2026 Край: 01.05.2030 Възраст: 18–70 г.

France University Hospital, Strasbourg, France NCT07545889

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Correcting Disinformation About Menthol Cigarettes and Flavored Cigars

Disinformation Menthol Cigarettes Flavored Cigars

Our study tests a multi-level anti- disinformation message (ADM) campaign on menthol cigarette and flavored cigar policies in Black adults.

Начало: 01.09.2026 Край: 31.01.2028 Възраст: от 18 г.

United States Rutgers, The State University of New Jersey NCT07543081

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A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

Venous Thromboembolism Children Under 2 Years

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: * Age, gender, and other information about the child and their illness * Type of VTE treatment given to the child * Occurrence of medically important bleeding and its severity Further information that researchers will collect: * Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE * Return of VTE symptoms * Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: * end of the anticoagulation treatment period e.g. discontinuation of all study drugs, * their information is no longer available, or * the study ends.

Начало: 01.09.2026 Край: 30.06.2029 Възраст: до 2 г.

Denmark, France, Spain +1 Bayer NCT05900388

Предстои набиране Фаза 1

Efficacy and Safety of Yiqi Wenyang Sanhan Formula Combined With Acupoint Application in Patients With Combined Allergic Rhinitis and Asthma Syndrome During Remission and Yang-Deficiency Syndrome

Allergic Rhinitis With Asthma

Allergic rhinitis-asthma syndrome is a clinical comorbid condition involving both upper and lower airway allergic inflammation, reflecting the concept of "one airway, one inflammatory response." Epidemiological studies have demonstrated a strong coexistence between allergic rhinitis and asthma: allergic rhinitis is present in a substantial proportion of patients with asthma, while some patients with allergic rhinitis may further develop concomitant asthma. Clinically, the disease is characterized by recurrent and fluctuating episodes, which are often associated with seasonal or persistent allergen exposure. In terms of symptomatology, upper airway manifestations mainly include nasal itching, paroxysmal sneezing, watery rhinorrhea, and nasal obstruction, whereas lower airway manifestations are primarily recurrent wheezing, shortness of breath, chest tightness, and cough. When these two conditions coexist, they not only increase the overall symptom burden but also further impair patients' quality of life and complicate disease control. During the remission stage, patients may exhibit alleviation of nasal and lower airway symptoms and may even enter a relatively "asymptomatic" state; however, this does not necessarily indicate complete resolution of airway inflammation. The Global Initiative for Asthma has emphasized that even in patients with only intermittent or infrequent symptoms, persistent airway inflammation may still be present. Therefore, the central goal of management during remission is not merely to wait for recurrence, but to reduce the risks of acute exacerbation and disease progression through standardized long-term intervention. Specifically, inhaled corticosteroid (ICS)-containing regimens should be maintained as the cornerstone of asthma control during remission, and sole reliance on short-acting β2-agonists should be avoided. Meanwhile, in patients with concomitant allergic rhinitis, nasal management should be carried out simultaneously, with intranasal corticosteroids particularly recommended. In addition, attention should be paid to allergen exposure control, correct use of inhalation devices, treatment adherence, and the assessment of comorbidities. Existing systematic reviews also suggest that conventional treatment for rhinitis may improve quality of life in patients with this comorbidity to a certain extent and may have favorable effects on some objective asthma outcomes, although its impact on overall asthma control remains somewhat heterogeneous. Precisely because patients with allergic rhinitis-asthma syndrome remain at risk of persistent inflammation, constitutional imbalance, and recurrent attacks during remission, traditional Chinese medicine (TCM) has considerable potential for intervention at this stage. TCM emphasizes the principle of "treating disease before its onset," namely, preventing illness before it arises and preventing progression once it has occurred. Its strengths lie not only in symptom control during the active phase, but also in the regulation of the overall bodily state, constitution-based differentiation, and the proactive management of recurrence risk during remission. The International Clinical Practice Guideline for Allergic Rhinitis in TCM, issued by the World Federation of Chinese Medicine Societies in 2024, has incorporated standardized frameworks for internal therapies, external therapies, constitution identification and regulation strategies, as well as preventive and nursing measures, highlighting the unique role of TCM in the long-term management of allergic airway diseases. At the same time, existing systematic reviews and narrative reviews suggest that interventions such as acupuncture, acupoint application, and Chinese herbal medicine may have certain potential in improving rhinitis symptoms, enhancing quality of life, and reducing recurrence rates in some patients; however, the overall quality of evidence and the consistency of findings still require further improvement. Based on the above considerations, the present study shifts the focus forward to the remission stage of allergic rhinitis-asthma syndrome, targeting this critical period in which symptoms may be temporarily alleviated but inflammation persists, and clinical stability coexists with an ongoing risk of recurrence. By using the Yiqi Wenyang Sanhan Formula combined with acupoint application therapy, this study attempts to explore the clinical value and practical significance of TCM intervention in the long-term management of this condition. Unlike research approaches that focus exclusively on the control of acute exacerbations, the present study places greater emphasis on the systematic evaluation of recurrence prevention, interruption of disease progression, and optimization of the overall patient condition, with the aim of providing evidence for whole-course management strategies more consistent with the characteristics of chronic allergic airway diseases.

Начало: 01.09.2026 Край: 31.12.2027 Възраст: 16–79 г.

Beijing Daxing District Hospital of Integrated Chinese NCT07540351

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