International Journal of Clinical Trials

Chemotherapy induced nausea-vomiting and breathing exercise: a review

Pınar Ekşi — 2025-07-23

The gradual deterioration of the functions of cells, that have great vital importance, can lead to various diseases in many organs and systems such as cancer that is the second cause of death in the worldwide. Some complications may occur with the initiation of chemotherapy and the quality of life of patients may become worse. Chemotherapy induced nausea and vomiting in cancer patients have continued to be one of the most common and disturbing symptoms in recent years. Nausea and vomiting may not seem dangerous on their own, but in many patients receiving chemotherapy, they can cause loss of appetite and consequent inability to eat, and death due to malnutrition. Today, the cause of nausea and vomiting is not completely understood and the pathophysiology of nausea cannot be even clearly explained. There is no definitive and effective drug treatment method for nausea and vomiting. This uncertainty has led to the use of various complementary and alternative treatment methods and breathing exercises have come into prominence in these treatment methods. In nursing practice, the intervention of breathing exercise in the clinical setting is mostly unknown or cannot be applied. For this reason, nurses may need to get help from a specialist trainer about breathing exercises to teach patients and guide them. This review provides information about breathing exercise to manage nausea and vomiting in cancer patients undergoing chemotherapy.

Steps and requirements of preparing trial master file and clinical trial manufacturing documentation

Sachin L. Sanap — 2025-07-23

The preparation of a trial master file (TMF) and clinical trial manufacturing documentation is fundamental to ensuring regulatory compliance, maintaining data integrity and supporting the successful execution of clinical trials. A well-organized TMF serves as a key repository for essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated, ensuring adherence to ICH-GCP (E6 R2), FDA, EMA and MHRA guidelines. With the increasing adoption of electronic trial master files (eTMF), sponsors and clinical research organizations (CROs) are transitioning towards centralized digital platforms to enhance data management, reduce compliance risks and facilitate real-time monitoring. This transition, however, presents challenges such as data migration complexities, system validation and maintaining audit readiness. Clinical trial manufacturing documentation plays a crucial role in ensuring the safety, quality and efficacy of investigational medicinal products (IMPs). Key documentation includes investigational medicinal product dossiers (IMPDs), master and batch manufacturing records (MBR/BMR), certificates of analysis (CoA), packaging and labelling records, stability reports and deviation/CAPA Reports. Compliance with good manufacturing practices (GMP), 21 CFR Part 211 and EU Annex 13 is essential to meet global regulatory expectations. Proper documentation ensures that clinical trial materials are manufactured, tested and distributed in accordance with predefined standards. This review outlines the stepwise process involved in preparing and managing a TMF and clinical trial manufacturing documentation. It highlights best practices for document organization, quality control and regulatory compliance, while also addressing challenges such as incomplete documentation, audit findings and evolving regulatory landscapes. Furthermore, the paper discusses the impact of digital transformation, including the role of artificial intelligence (AI) and blockchain in enhancing documentation security, efficiency and traceability.

Digital transformation of clinical research: facilitating decentralized clinical trials in India

Astha R. Tambe — 2025-07-23

The decentralized clinical trials make clinical research accessible by using digital tools such as e-consent, telehealth, and remote monitoring. Decentralized clinical trials in India have the potential to reduce participant burden and increase trial participation. However, the nation's disparate healthcare system, digital divide, and changing regulatory environment make broad adoption difficult. The current status of decentralized clinical trials in India is examined in this review, including significant operational, regulatory gaps, and potential implementation strategies. The aim is to offer information which will help in scaling decentralized clinical trials in India. This review compiles findings from journals, regulatory guidelines, white papers, blogs and case studies from Indian decentralized clinical trial platforms. It focuses on trends, logistical challenges, regulatory readiness in decentralized clinical trials implementation in the Indian context. To support key details tables and figures are used. India's pilot decentralized clinical trials demonstrate increased cost-effectiveness and reach, particularly when it comes to extending access outside of cities. However, region-specific infrastructure deficiencies, untrained staff for decentralization operations, and absence of e-consent provisions in New Drugs and Clinical Trial Rules 2019, restricts scalability. The 2024 draft guidance of United States’s Food and Drug Administration provides framework for decentralized clinical trials which can be implemented in India. In order to ensure ethical, and successful implementation of decentralized clinical trials for India's diverse healthcare system investment in digital health infrastructure, regulatory revisions, and site personnel training for decentralized clinical trial operations is necessary.

Decentralized clinical trials-balancing promise and pitfalls in modern research: a systematic review

Arghya Biswas — 2025-07-23

Background: Traditional clinical trials often face limitations in participant diversity and accessibility due to geographic and logistical constraints. Decentralized clinical trials (DCTs) have emerged as a potential solution to address these challenges by leveraging digital and remote technologies. Despite their advantages, there remains a lack of comprehensive understanding regarding the opportunities and challenges associated with DCTs. This systematic review explores the opportunities and challenges of DCTs, providing insights into their implementation and impact on clinical research. The review analyses DCTs' effects on trial conduct and outcomes, offering recommendations for future design and execution.

Methods: A systematic literature review was conducted following PRISMA guidelines, searching major databases for studies published between 2018 and March 2024. The review analyzed 18 peer-reviewed articles, assessing risk of bias using an adapted Cochrane tool.

Results: The results highlighted that DCTs enhance participant engagement, improve accessibility and increase participant diversity, offering potential cost savings and improved trial efficiency. However, challenges such as ensuring data integrity, overcoming technological barriers and addressing regulatory compliance were also noted. The majority of the included studies demonstrated a low risk of bias across all domains, enhancing the reliability of these findings.

Conclusions: This review underscores DCTs' potential to transform clinical research by improving efficiency, accessibility and participant diversity. Successful implementation requires addressing technological, ethical and regulatory challenges. Future research should focus on standardized best practices, equity issues and comparative studies with traditional trials. These findings have significant implications for shaping future clinical trials.

Advanced statistical methods for the analysis of data in cosmetic science studies

Maheshvari Patel — 2025-07-01

Statistical analysis is fundamental to cosmetic research, enabling rigorous evaluation of product safety, efficacy, and consumer perception. Despite its importance, the selection and application of statistical methodologies in cosmetic studies remain varied and lack a comprehensive synthesis. This systematic review examines the statistical methods employed in clinical cosmetic research, focusing on both commonly used practices and advanced biostatistical techniques. Following PRISMA guidelines, a literature search was conducted using PubMed with the keywords “statistical + cosmetic products,” restricted to studies published between January 2000 and April 23, 2025. After applying inclusion and exclusion criteria, 37 full-text articles involving human subjects and reporting statistical methodologies were included. Data on study design, sample size, outcome measures, and statistical methods were extracted and analysed. Parametric tests such as paired t-tests, independent t-tests, and ANOVA were commonly used for continuous outcomes, while non-parametric alternatives, including the Wilcoxon signed-rank test, Mann-Whitney U test, and Kruskal-Walli’s test, were applied when normality assumptions were not met. Longitudinal data analysis frequently employed repeated measures ANOVA and mixed-effects models, with Bonferroni correction for multiple comparisons. Categorical data were analysed using chi-square tests, McNemar’s test, Fisher’s exact test, and logistic regression. More advanced methods, such as ANCOVA, Bland-Altman plots, two one-sided tests (TOST) for bioequivalence, and meta-analytic techniques using Cochran’s Q and I² statistics, were also identified. Overall, cosmetic research demonstrates broad and largely appropriate statistical application, although improved reporting of assumptions and model specifications is recommended to enhance transparency and reproducibility.

The efficacy of Licorice (Glycyrrhiza glabra) in reducing pain, as compared to other pharmacological interventions, including placebo, in recurrent aphthous stomatitis, oral lichen planus and radiation-induced oral mucositis: a systematic review

Disha Vijay Alhat — 2025-07-23

Licorice (Glycyrrhiza glabra) is one of the oldest medicinal herbs, also reported by Avicenna, with several therapeutic advantages such as wound healing, improvement of asthma, urinary infections and stomach ulcers, as well as pain-relieving characteristics. The review aims to assess the efficacy of licorice (Glycyrrhiza glabra) in reducing pain compared to other pharmacological interventions, including placebo, in recurrent aphthous stomatitis, oral lichen planus and radiation-induced oral mucositis. Four electronic databases, registries of current studies and a manual search were used to find randomized controlled trials (RCTs) that evaluated the effectiveness of licorice (Glycyrrhiza glabra) in reducing pain compared to other pharmacological interventions, including placebo, in recurrent aphthous stomatitis, oral lichen planus and radiation-induced oral mucositis patients up to December 2022. The primary outcomes were pain reduction and secondary outcomes included reduction in size of the lesion. Seven RCTs with a total of 326 patients were included. Our analysis indicated that Licorice is as effective as other pharmacological and placebo therapies in treating recurrent aphthous ulcer, oral lichen planus and oral mucositis. All of the RCTs that are included here showed a substantial decrease in visual analogue scale scores, demonstrating the efficacy of liquorice in comparison to other pharmaceutical therapies with negligible adverse effects. Thus, Licorice is a potential pain reducing herbal medicine and can be effectively used in oral lesions like RAS, OLP, radiation induced mucositis for relieving pain.

Risk factors for hip and groin injuries in male football players: a systematic review protocol

Konstantinos Vassis — 2025-07-23

Background: Hip and groin injuries are common among male football players and represent a significant burden due to their frequency, recurrence, and associated time-loss. Despite numerous studies on risk factors, methodological inconsistencies and lack of sport-specific synthesis have limited the development of effective prevention strategies. The aim of this protocol is to conduct a systematic review to identify and evaluate the risk factors associated with hip and groin injuries in male football players.

Methods: This review will be conducted in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and registered in the International prospective register of systematic reviews (PROSPERO). A comprehensive search will be performed across 7 databases, including Ovid MEDLINE, PubMed, PsycINFO, ScienceDirect, Scopus, SportDiscus, and Web of Science, from inception to June 2025. Studies will be included if they examine risk factors for hip and groin injuries in male football players aged ≥18 years. Two independent reviewers will perform screening, data extraction, and risk of bias assessment using the QUIPS tool. A best-evidence synthesis approach will be used to summarize the strength of evidence for each identified risk factor.

Conclusions: Identifying consistent risk factors for hip and groin injuries in male football players will provide an essential foundation for developing evidence-based and sport-specific prevention strategies in clinical and performance settings.

Trial registration: PROSPERO registration number is CRD420251042372.

A study protocol to develop and assess the utility of a Dinacharya habit-tracking mHealth app towards modification of health behaviour of study subjects

Sadhna Kumar — 2025-06-25

Background: Dinacharya (daily regimen) in Ayurveda are health practices that sync with circadian rhythms, and promote holistic health. Mobile health apps (mHealth) are widely adopted tools of behavioural change communication to implement health behaviours. However, there is still significant scope for mHealth research in Ayurveda. In particular, there is a noticeable lack of high-quality, authentic, educational and interactive habit-tracking apps based on Dinacharya principles. The objective of this study is to develop and assess the utility of Dinacharya Habit-Tracking mHealth App on the health behavior of subjects.

Methods: The study has 3 parts: design and validate Dinacharya guidelines and Dinacharya KAP questionnaire (Delphi method); develop a habit-tracking Dinacharya app and multimedia database, and assess the app’s effectiveness on health behaviour outcomes of the study subjects with a prospective randomized controlled trial. 72 healthy volunteers, aged between 18 to 65 years, English speaking and mobile literate will be recruited. Participants will be randomized into the trial group receiving the app intervention (n=36) and the control group receiving Dinacharya printed material intervention (n=36), for 4 weeks. Primary outcomes include frequency of habit adoption, and knowledge, attitudes and practice of Dinacharya. Secondary outcomes include objective and subjective assessment of feasibility, usability, navigation, motivation, and overall rating via the Mobile app rating scale (MARS) and semi-structured interviews, respectively. The outcomes will be assessed at baseline, week 1, week 2, week 3, and post-intervention.

Conclusions: The findings from this study will offer empirical data on the effectiveness of mHealth in promoting healthy habits, and educating users about Dinacharya. Findings may guide development of future Ayurveda-based apps by demonstrating how digital tools can support user engagement and integrate traditional wellness principles into modern healthcare.

Trial Registration: CTRI-Clinical Trial Registry of India (CTRI/2025/06/089328).

The efficacy of mud pack to eyes on cognitive functions among depressed adolescents: a study protocol for randomized controlled trial

Sathiyanandham Muniyappan — 2025-07-23

Background: Mud pack to eyes is a naturopathic treatment that involves applying mud pack directly over closed eyes. Mud pack will be prepared by wrapping the soaked mud in a cotton fabric strip. Mud pack to eyes are regarded to have therapeutic benefits, particularly for the treatment of stress-related symptoms and for the promotion of relaxation. Despite its extensive use in naturopathic practice, there is currently very little research investigating the precise effects of mud pack to eyes on cognitive functions, particularly in adolescents with depression.

Methods: In this study protocol, a randomized control design will be used. Eligible people will be randomly assigned to study and control groups. 40 participants in study group will get 30-minute mud pack to eyes intervention once a day for four weeks (5 days a week). Control group (n=40) will rest in supine position for 30 minutes once a day for four weeks (5 days a week). Assessments such as critical flicker fusion frequency (CFFF), auditory reaction time (ART), visual reaction time (VRT), BDI-II (Beck’s depression inventory) scores and MAAS (Mindfulness attention awareness scale) scores of both study and control group participants will be assessed before and after the interventions.

Conclusions: Mud pack to eyes intervention is an easy and efficient method of enhancing mindfulness and cognitive functions as well as reduce the symptoms of depression among depressed adolescents.

Trial registration: This study was prospectively documented in clinical trial registry of India (CTRI/2023/10/ 059052).

Comparative effectiveness of posture correction exercises versus postural awareness on forward head posture, protruded shoulder and thoracic kyphosis in 13-15 year old smartphone users: a randomized controlled trial intervention protocol

Vinutha Bhandary — 2025-07-23

Background: Rise in smartphone use among high school students aged 13-15 has leads to musculoskeletal issues like forward head posture (FHP), protruded shoulders, and thoracic kyphosis. To prevent these problems, it's essential to teach students proper posture exercises and raise their awareness about maintaining good posture. Primary objective of this study is to determine the efficacy of posture correction exercises and postural awareness techniques on FHP, protruded shoulder, and thoracic kyphosis.

Methods: This randomized clinical trial will assess the impact of an intervention on FHP, protruded shoulders, and thoracic kyphosis in 170 smartphone addicted participants who will be randomly allocated to control and interventional group. Smartphone addiction will be measured using the smartphone addiction scale-short version (SAS-SV), and postural changes will be evaluated with cranio vertebral angle (CVA), the supine method, and an inclinometer measurement before and after the intervention. Follow up will be done after 3- and 6-months post intervention. If data is normally distributed, paired ‘t’ test and independent ‘t’ test will be used for in group and between group analysis, ANOVA with post-hoc test (Bonferroni-t test) for follow up analysis otherwise non parametric equivalent tests will be used. The results will be presented in the form of 95% CI and with p≤0.05.

Conclusions: If postural correction exercises and awareness effectively reduce FHP, protruded shoulders, and thoracic kyphosis in 13-15-year-old smartphone users, integrating these techniques into daily routines could prevent future postural issues related to smartphone addiction.

Trial registration: This randomized clinical trial registered prospectively. Registration Number: CTRI/2024/07/ 069802.

Effect of vitamin E as an add-on therapy on oxidative stress in patients with epilepsy: a randomized placebo-controlled trial

Anusha Natarajan — 2025-07-23

Background: Epilepsy, a chronic neurological disorder, is often complicated by oxidative stress due to long-term antiepileptic drug (AED) use. While preclinical studies suggest vitamin E may mitigate oxidative damage, its clinical efficacy as adjunctive therapy in epilepsy remains underexplored.

Methods: This randomized, double-blind, placebo-controlled trial enrolled 60 adults with epilepsy on stable AED therapy at JIPMER, Puducherry (March 2022-March 2024). Participants were allocated to either vitamin E (400 mg/day) or placebo for two months. Primary outcomes included changes in oxidative stress biomarkers [total antioxidant capacity (TAC), catalase, glutathione (GSH), malondialdehyde (MDA)]. Secondary outcomes assessed EEG changes, seizure-free intervals, and metabolic syndrome incidence. Statistical analysis used ANOVA/Kruskal-Wallis for biomarkers and repeated-measures ANOVA for EEG.

Conclusions: This study aims to determine whether vitamin E supplementation reduces oxidative stress and improves clinical outcomes in epilepsy patients, potentially informing future antioxidant-based adjunctive therapies.

Trial registration: CTRI/2022/04/041902 (Clinical trials registry-India).

Impact of the COVID-19 pandemic on the distribution and resistance of multidrug-resistant genes in Minas Gerais, Brazil: challenges and implications

Hoberdan Oliveira Pereira — 2025-07-23

Background: Following the COVID-19 pandemic, a significant rise in multidrug-resistant pathogens such as Acinetobacter, Enterobacter, Escherichia, Klebsiella, Providencia, Pseudomonas and Serratia spp. was observed in Minas Gerais, Brazil. Diagnostic disparities and antimicrobial overuse for COVID-19-associated pneumonia likely contributed to resistance gene spread.

Methods: This retrospective, cross-sectional, descriptive study analysed 13,012 Gram-negative bacterial isolates collected from hospitals across Minas Gerais between 2016 and 2022. Samples, including urine, tracheal secretion, blood and surgical wound exudate, were referred to the state public health laboratory (LACEN-MG) based on resistance patterns detected via antibiograms. Genotypic analysis involved PCR screening for resistance genes (blaKPC, blaOXA, blaNDM, blaSPM, blaVIM, blaIMP), categorized by pandemic period (pre-, during and post-COVID-19). The presence of at least one gene indicated multidrug resistance.

Results: Among isolates, 70.8% were fermenting bacilli, mainly Klebsiella spp. (73.8%), 29.2% were non-fermenting, mostly Acinetobacter spp. (62.1%) and Pseudomonas spp. (37.9%). Post-pandemic resistance increased significantly (p<0.05). blaKPC declined in relative frequency (66.3% pre-pandemic to 44.4% post-pandemic) but absolute numbers rose (n=2,906). blaOXA and blaNDM increased to 41.1% and 13.5%, respectively, with blaNDM increasing over sixfold. Mcr-1 appeared exclusively post-pandemic in four isolates. blaSPM, blaVIM and blaIMP remained rare; blaIMP was detected only post-pandemic (0.24%, n=16).

Conclusions: Post-pandemic, resistance gene profiles diversified, with expansion of blaOXA, blaNDM and emergence of mcr-1. Strengthened molecular surveillance, equitable diagnostic access and antimicrobial stewardship are urgently needed in Brazil.

Life style modification regimen on polycystic ovary syndrome among adolescent girls

Hemavathi P. — 2025-07-23

Background: Polycystic ovary syndrome (PCOS) is to be a growing problem among adolescent girls. Sedentary lifestyles, lack of exercises and fast-food consumption leading to the risk of developing of polycystic ovarian disease. This Quasi experimental one group pre and post-test times series design aimed to assess the effect of lifestyle modification regimen (LSMR) on PCOS among Adolescent Girls.

Methods: Total 953 Adolescent girls were screened by modified PCOS risk assessment checklist. Study was conducted among 171 Adolescent girls with moderate risk of PCOS and BMI 23 and above. Data was collected on lifestyle habits, body weight, BMI, Acne and Menstrual patterns. Followed that LSMR implemented for four months and monitored by weekly food diary and exercise diary. Post-test-1, post-test-2 and post-test-3 data was collected and analysed using SPSS 27.

Results: Study completed with 153 participants. Significant reduction in the PCOS risk score was observed with mean difference 3.46 and the calculated ‘t’ value was 40.927 at p <0.01. Lifestyle habits show mean difference of dietary habit and Physical activity score was 22.04 &13.90 respectively and calculated ‘t’ value was 37.587 and 36.908 at p <0.01 respectively. Anthropometric measurements shows that mean difference of body weight and BMI score was 4.38 and 1.93 respectively and calculated ‘t’ value was 27.897 and 16.597, at p <0.01 respectively. There was improvement in acne and menstrual pattern after LSMR.

Conclusions: LSMR plays vital role in the control and management of PCOS.