Contemporary Clinical Trials Communications最新文献

{"title":"Efficacy and safety of Chinese medicine compound for the convalescent COVID-19 patients: Protocol of a multi-centered, randomized, double-blinded, placebo-controlled clinical trial","authors":"Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge","doi":"10.1016/j.conctc.2025.101557","DOIUrl":"10.1016/j.conctc.2025.101557","url":null,"abstract":"<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101557"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time-restricted eating in Alzheimer's disease: TREAD pilot trial design","authors":"Susan B. Racette ,&nbsp;Jordan A. Gunning ,&nbsp;Danielle E. Eagan ,&nbsp;Isabella Zaniletti ,&nbsp;Tracy L. Smith ,&nbsp;Candice J. DeCuna ,&nbsp;Yehansa S. Hettiwatte ,&nbsp;Migbare T. Demeke ,&nbsp;Nevine A. Khan ,&nbsp;Emily L. Aliskevich ,&nbsp;Janina Krell-Roesch ,&nbsp;Yonas E. Geda","doi":"10.1016/j.conctc.2025.101564","DOIUrl":"10.1016/j.conctc.2025.101564","url":null,"abstract":"<div><h3>Background and objective</h3><div>Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE.</div></div><div><h3>Methods</h3><div>TREAD is an intervention trial for 30 adults aged 55–89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency.</div></div><div><h3>Summary</h3><div>TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101564"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for the rural engagement in TelemedTeam for options in obesity treatment solutions (RE-TOOL): Cluster randomized trial investigating team-based telemedicine in rural primary care","authors":"Alexandra R. Brown ,&nbsp;Edward F. Ellerbeck ,&nbsp;Debra K. Sullivan ,&nbsp;Eve-Lynn Nelson ,&nbsp;Jennifer R. Klemp ,&nbsp;Byron J. Gajewski ,&nbsp;Jarron Michael Saint Onge ,&nbsp;Christie A. Befort","doi":"10.1016/j.conctc.2025.101559","DOIUrl":"10.1016/j.conctc.2025.101559","url":null,"abstract":"<div><div>Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101559"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of an integrated treatment for fathers with Co-occurring substance misuse and family violence","authors":"Carla S. Stover ,&nbsp;Sarah Meshberg-Cohen ,&nbsp;Galina A. Portnoy ,&nbsp;Satvika Char ,&nbsp;Carter W. McCaskill ,&nbsp;Quyen A. Do ,&nbsp;James Dziura ,&nbsp;Steve Martino","doi":"10.1016/j.conctc.2025.101555","DOIUrl":"10.1016/j.conctc.2025.101555","url":null,"abstract":"<div><div>Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101555"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Bud App: A protocol for a randomized controlled trial with an internal pilot phase targeting modifiable risk and protective factors for suicide among international students","authors":"Samuel McKay ,&nbsp;Christina Ng ,&nbsp;Jennifer Nicholas ,&nbsp;Vivienne Browne ,&nbsp;Gina Chinnery ,&nbsp;Isabella Choi ,&nbsp;Bailey Nation-Ingle ,&nbsp;Kristal Alison ,&nbsp;Ella Perlow ,&nbsp;Michelle Lamblin ,&nbsp;Elise Carrotte ,&nbsp;Ellie Brown ,&nbsp;Gregory Armstrong ,&nbsp;Jocelyn I. Meza ,&nbsp;Madhavan Mani ,&nbsp;Jo Robinson","doi":"10.1016/j.conctc.2025.101578","DOIUrl":"10.1016/j.conctc.2025.101578","url":null,"abstract":"<div><div>International students face elevated risk for mental health problems and suicide, yet encounter multiple barriers to accessing timely and culturally responsive treatments. Key challenges include high rates of psychological distress, low mental health literacy, and reduced help-seeking, often compounded by perceived burdensomeness, a lack of belonging, and difficulties with emotion regulation. Bud is a self-guided, co-designed mobile app developed to address these challenges through an accessible digital intervention. This paper outlines a protocol for a randomized controlled trial evaluating the effectiveness, acceptability, engagement, and safety of Bud among international students enrolled at Australian tertiary institutions. The trial also includes an internal pilot phase to ensure the feasibility of the trial procedures, with benchmarks for recruitment, retention, and engagement. A community sample of 302 participants will be randomly assigned to either the intervention group (Bud app) or the active control group (online mental health fact sheets) for four weeks. Assessments will be completed online at baseline, two weeks, and four weeks post-baseline. The primary outcome is psychological distress, with secondary outcomes including help-seeking intentions, perceived burdensomeness and belonging, emotion regulation, mental health literacy, and suicidal ideation. Acceptability and engagement will be assessed using self-report and objective measures. Interviews will be conducted with a subset of 20 participants to explore their views on Bud further. This trial will provide the first evaluation of a suicide prevention tool specifically for international students. If effective, Bud could offer a scalable and culturally relevant solution to improve student mental health and reduce service access barriers.</div></div><div><h3>Trial registration</h3><div>ACTRN12625000584437.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101578"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retraction notice to “Filipinos Fit and trim - A feasible and efficacious DPP-based intervention trial” [Contemporary Clinical trials Communications 12 (2018) 76–84]","authors":"Melinda S. Bender ,&nbsp;Bruce A. Cooper ,&nbsp;Elena Flowers ,&nbsp;Raymond Ma ,&nbsp;Shoshana Arai","doi":"10.1016/j.conctc.2025.101573","DOIUrl":"10.1016/j.conctc.2025.101573","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101573"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of delayed study startup on accrual in cancer studies","authors":"Isuru Ratnayake ,&nbsp;Anh-Tuan Do ,&nbsp;Daniel Gajewski ,&nbsp;Sam Pepper ,&nbsp;Oluwatobiloba Ige ,&nbsp;Natalie Streeter ,&nbsp;Tara L. Lin ,&nbsp;Matthew McGuirk ,&nbsp;Byron Gajewski ,&nbsp;Dinesh Pal Mudaranthakam","doi":"10.1016/j.conctc.2025.101562","DOIUrl":"10.1016/j.conctc.2025.101562","url":null,"abstract":"<div><h3>Background</h3><div>Drug development in cancer medicine relies on high-quality clinical trials, and the success of these trials depends on the design, optimization, and execution. Delays often arise from the study startup process, which can take 6 months or more. Complex challenges, including regulatory hurdles, contract negotiations, and inefficiencies in site activation, contribute to these delays. Streamlining these processes is critical to accelerating patients' access to potentially life-saving therapies.</div></div><div><h3>Method</h3><div>Data from the University of Kansas Cancer Center (KUCC) were used to analyze studies initiated between 2018 and 2022. The accrual percentage was computed based on the number of enrolled participants and the desired accrual goal. Accrual success was determined by comparing the enrollment rate to predefined threshold values (50 %, 70 %, or 90 %).</div></div><div><h3>Results</h3><div>Studies that achieve or surpass the 70 % accrual threshold typically exhibit a median activation time of 140.5 days. In contrast, studies that fall short of the accrual goal tend to have a median activation time of 187 days, indicating shorter median activation times are associated with successful studies. The Wilcoxon rank-sum test (W = 13,607, p = 0.001) indicated that early-phase studies had significantly longer activation times than late-phase studies. We also conducted the study with 50 % and 90 % accrual thresholds; our findings remained consistent.</div></div><div><h3>Conclusions</h3><div>Longer activation times are associated with lower project success, and early-phase studies tend to be more successful than late-phase studies. Therefore, by reducing impediments to the approval process, we can facilitate quicker approvals, increasing the success of studies regardless of phase.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101562"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The culturally adapted cognitive behavioral stress management program for enhancing psychological well-being and self-management of postoperative breast cancer patients: A randomized controlled study protocol in China","authors":"Linzhi Jiang ,&nbsp;Rongrong Liu ,&nbsp;Xingqun Tan ,&nbsp;Fan Wang ,&nbsp;Liyuan Sun","doi":"10.1016/j.conctc.2025.101567","DOIUrl":"10.1016/j.conctc.2025.101567","url":null,"abstract":"<div><h3>Introduction</h3><div>Breast cancer patients often face mental health challenges after prolonged treatment. High incidence and mortality rates, coupled with a shortage of healthcare professionals and heavy clinical workloads, frequently lead to the neglect of psychological care. Developing a targeted and effective psychological intervention for breast cancer patients is therefore crucial. This study aims to evaluate the efficacy of a culturally adapted cognitive behavioral stress management (CBSM) program on postoperative psychological well-being, disease-related symptoms, and self-management among breast cancer patients in China.</div></div><div><h3>Methods and analysis</h3><div>A total of 72 postoperative breast cancer participants will be randomly assigned to either the intervention group or the control group. This study adopts a randomized controlled design with repeated post-test measurements. Key outcome variables, including benefit finding (primary outcome), social support, perceived stress, self-management, and quality of life (secondary outcomes), will be assessed at four time points: baseline, 1 month, 3 months, and 6 months after the intervention.</div></div><div><h3>Discussion</h3><div>This study provides a structured psychological intervention tailored to postoperative breast cancer patients in China, offering a theoretical basis for clinical psychological care in oncology settings. The findings are expected to clarify the role of the culturally adapted CBSM program in enhancing benefit finding, improving social support and self-management, and alleviating stress while boosting quality of life. By testing the adapted CBSM in the Chinese cultural context, with implications for refining cross-cultural psychological support strategies for breast cancer patients.</div></div><div><h3>Trial registration</h3><div>Chinese Clinical Trial Registry: ChiCTR2500101510; registration date: April 25, 2025.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101567"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences","authors":"Carlos Almonacid ,&nbsp;Borja G. Cosío ,&nbsp;Xavier Muñoz Gall ,&nbsp;Manuel Santiñà Vila ,&nbsp;Jaime Signes-Costa ,&nbsp;José Luis Velasco Garrido ,&nbsp;Mercedes Luz ,&nbsp;Marta Rodríguez ,&nbsp;Alberto Godos ,&nbsp;Ana Pérez Domínguez ,&nbsp;Eunice Funenga ,&nbsp;Carmen Moreno","doi":"10.1016/j.conctc.2025.101544","DOIUrl":"10.1016/j.conctc.2025.101544","url":null,"abstract":"<div><div>Clinical trials (CT) are the framework upon which novel treatments' safety and efficacy are assessed. The CARABELA-CT initiative aims to optimise Spanish CT procedures by improving efficiency, quality, and subject well-being. To this, it characterised CT healthcare models, identified improvement areas, proposed solutions, and gathered important insights from CT subjects. CARABELA-CT took a three-phase approach. Phase I involved CT healthcare models’ characterisation, including all clinical investigation processes in Spain, across six pilot hospitals, identifying improvement areas and solutions. Phase II validated these findings, defining key healthcare quality indicators. Phase III focused on dissemination and implementation. Additionally, seven randomly invited CT subjects participated in a focus group to share their experiences regarding communication, coordination, and CT impact on quality of life. Three CT healthcare models were identified, distinguished according to access, infrastructure, and resources. Twelve improvement areas were defined, leading to 38 solutions addressing subject education, professional training, organisation, protocols, resources, and technology. Twenty-four healthcare quality indicators were established to monitor CT processes. Subject experiences highlighted the need for clearer communication, digitalised information, and improved subject support, and revealed the emotional and psychological benefits of CT participation, despite the challenges. CARABELA-CT provides a comprehensive framework to enhance Spanish CT processes. This initiative integrates potential solutions in improvement areas in CT development and the corresponding healthcare quality indicators, and prioritises subject experiences to foster efficiency, participant engagement, and a sustainable, patient-centric clinical research model. These findings contribute to the continuous improvement of CT management, ultimately optimising research execution and healthcare outcomes.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101544"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A protocol for management of presbyopia through ancient yogic eye purificatory method: A randomized controlled trial","authors":"Lavya Shetty ,&nbsp;Yogish Subraya Kamath ,&nbsp;Annapoorna K ,&nbsp;Gitika Bhasin ,&nbsp;Akhilesh Kumar Pandey","doi":"10.1016/j.conctc.2025.101563","DOIUrl":"10.1016/j.conctc.2025.101563","url":null,"abstract":"<div><div>Presbyopia is an age-related eye condition observed in older people (who are above 40 years), whereby there is a gradual loss of the ability to focus on near items. Some common symptoms include seeing near as blurred, eye strain, and a headache, which may impair the quality of life. The general solution to presbyopia using corrective lenses or surgery interventions has been available. But the emergent philosophy focuses on non-pharmacological methods, such as yogic eye practice and Trataka Kriya. This technique involves steady gazing designed to enhance the function of ocular muscles and improve near vision. This current study outlines a single-blind randomized controlled trial to evaluate Trataka Kriya's effectiveness in managing presbyopia. A total of 286 participants will be recruited, all above 35 years of age with a confirmed diagnosis of presbyopia. The participants will be randomly allocated into two groups, where one will receive standard medical care and the other will receive the practice of Trataka Kriya in addition to standard medical care. The intervention plan will be 12 weeks, where visual acuity, eye strain, and other eye-related characteristics will be assessed at the beginning and end of the intervention. The primary outcomes will be near visual acuity and eye strain, with secondary outcomes including other eye-related characteristics. The protocol outlines key criteria to evaluate whether the addition of Trataka Kriya to standard care is effective in improving near vision and reducing eye strain symptoms in individuals with presbyopia.</div></div><div><h3>Trial registration</h3><div>Clinical Trials Registry - India (CTRI); Registration number: CTRI/2023/09/057523; Registration Date: September 12, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101563"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}