International Journal of Clinical Trials

Journal Information
ISSN / EISSN : 2349-3240 / 2349-3259
Published by: Medip Academy (10.18203)
Total articles ≅ 293
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Sucheta Gupta, Vinod Gupta
International Journal of Clinical Trials;

Background: Chronic suppurative otitis media (CSOM) is an important and a highly prevalent disease of the middle ear and poses serious health problem worldwide especially in developing countries. The objective of the current study was to evaluate the association between CSOM and sensorineural hearing loss (SNHL) and to study of pattern of hearing loss and clinical factors and demographic variables, if any, that might affect sensorineural component, in CSOM in North-Indian population. Methods: A randomized observational study was conducted on 120 patients, in the age-group of 1 to 50 years, divided into two groups of 60 each: who had safe CSOM and unsafe CSOM, over a period of 6 months, i.e., from: July 2021 to December 2021, in the department of otorhinolaryngology and head neck surgery, CHC, Chenani, Udhampur, J and K, India. Results: Out of 60 patients under safe CSOM, Male: Female ratio stood at 1:1.14 (i.e., 28:32). Mean duration ± SD of the disease stood at: 6.2±5.09 years. Incidence of hearing loss was observed in 93 (77.5%) patients of conductive type and 27 (22.5%) patients of mixed type and 19 patients (31.67%) were of unsafe mixed type. Maximum incidence of 35% was in the age group of 41-50 years and minimum in 11-20 years i.e., 7.32%. Total incidence of SNHL 16.67%. Conclusions: A significant association between SNHL and CSOM was found in this study, with incidence of SNHL increasing with advancing age, showing that age as a risk factor for sensorineural component of hearing loss in CSOM.
Snehal Muchhala, Seema Bhagat, Rahul Rathod, Amey Mane, Bhavesh Kotak
International Journal of Clinical Trials, Volume 9, pp 221-226;

Background: Depression and anxiety are most disabling psychiatric conditions and add significantly to global health-related burden. Lifetime prevalence of major depression and anxiety disorders are very common and many times they can co-exist in the same time frame. The outcomes are poorer in such situations and compliance to medication is key to improve prognosis. A combination of tricyclic antidepressants and benzodiazepine is more practical in terms of compliance, and advantageous than that of a single class of drugs for the management of depression with co-morbid anxiety. This study will evaluate the safety and effectiveness of a fixed dose combination of amitriptyline and chlordiazepoxide as a part of post marketing surveillance. Methods: This is a prospective, single-arm, multi-centre, study which enrols patients who have been initiated with FDC of amitriptyline and chlordiazepoxide (Libotryp®: amitriptyline 12.5 mg and chlordiazepoxide 5 mg or libotryp-DS®: amitriptyline 25 mg and chlordiazepoxide 10 mg) tablets for the treatment of depression with co-morbid anxiety. A total of 375 patients will be enrolled and clinical assessments for safety will be done at follow up visits; assessments for effectiveness will be done using Hamilton Depression Rating Scale (HDRS or HAM-D) and Hamilton Anxiety Rating Scale (HARS or HAM-A). Conclusions: This study will provide more evidence on safety and usefulness of FDC of amitriptyline and chlordiazepoxide for the treatment of depression with co-morbid anxiety from Indian context. Trial registration: Trial registration number is CTRI/2021/03/031971.
Olakunle I. Makinde, Samuel E. O. Aigere, Nuvie Oyeyemi, Adedotun D. Adesina
International Journal of Clinical Trials, Volume 9, pp 187-196;

Background: Pain management post-caesarean section is a common source of exposure to opioids in women. To address the rising opioid addiction associated with peri-operative administration, trend in operative analgesia is moving towards opioid-free, multimodal analgesia. We present our protocol for this study so that it may be replicated in other settings and possibly modified for future studies. Methods: In a Single-centre, non-inferiority, parallel, randomized, controlled, clinical trial with balanced allocation [1:1] into two arms, we compared a peri-operative opioid-free analgesia regimen with a routine post-operative opioid-based analgesia regimen in women undergoing caesarean section under spinal anaesthesia. Primary outcome measures were post-operative pain intensity at 4, 8 and 24 hours (using Numerical Rating Scale) and post-operative pentazocine use. Secondary outcome measures were the incidence of adverse events and Apgar score. Results will be published in a peer-reviewed, open access journal. Conclusions: This protocol adopted the use of intravenous paracetamol and intravenous NSAID as baseline analgesics. Magnesium sulphate was introduced peri-operatively as part of our opioid-free multimodal analgesia regimen because of its established effect in decreasing post-operative pain and opioid use. We also relied on the preventive analgesic effect of administration of intravenous paracetamol and intravenous magnesium sulphate before surgical incision, continued intraoperatively and post-operatively. In addition, magnesium sulphate is a familiar drug to the obstetrician, readily available and affordable in most settings where comprehensive emergency obstetric care is offered, easy to administer and it has been well tolerated clinically. Trial registration: This protocol was registered with (Identifier: NCT04539249) on September 3, 2020, prospectively.
Soumya R. Panda, Vijayan Sharmila, Vinoth Kumar Kalidos, Smrutismita Hota
International Journal of Clinical Trials, Volume 9, pp 217-220;

Background: Both clomiphene (CC) and letrozole are commonly used oral ovulation induction agents, with different mechanism of action. Apart from letrozole or CC, options for ovulation induction in polycystic ovarian syndrome (PCOS) patients are limited and thus leaving the use of gonadotropin injections as the only option of ovulation induction in these patients. The objective of this study is to evaluate the efficacy of combined therapy of letrozole and CC compared to the use of letrozole alone to achieve ovulation in infertile women with PCOS. Methods: This will be a single-centre, double arm, triple-blind randomized controlled trial. The study was conducted after taking approval from institutional ethics committee and was prospectively registered with the clinical trials registry- India. Women were randomly assigned to receive a combination of 2.5 mg letrozole and placebo daily or a combination of 2.5 mg letrozole and 50 mg CC daily on cycle days 3–7 for one treatment cycle. Conclusions: If combination of clomiphene and letrozole is proved to be more efficacious than letrozole alone, there will be several breaks through advantages in the management of infertility. The novel method of ovulation induction with combined letrozole and clomiphene will bring down overall cost of infertility treatment. Trial registration: The study is prospectively registered with the clinical trials registry- India CTRI/2020/09/028012.
Stephanie Y. Wang, Zac Morse
International Journal of Clinical Trials, Volume 9, pp 211-216;

Background: Anxiety disorders are highly prevalent and are considered the most common psychiatric condition globally. Acupressure is a non-invasive alternative to acupuncture and has demonstrated effectiveness in managing psychosomatic disorders. However, due to high disparities within existing clinical research, it is difficult to recommend the optimum acupressure practice for anxiety management. This manuscript details the protocol for scoping the available evidence, mapping key concepts, and identifying gaps for future research. Methods: This protocol is designed following the preferred reporting items for systemic reviews and meta-analyses extension for scoping reviews (PRISMA-ScR) and the Joanna Briggs institute (JBI) manual for evidence synthesis guidelines. Six electronic databases (MEDLINE, CINAHL, AMED, PsycINFO, dentistry and oral science source, and Scopus) and two other search engines (Google and Google Scholar) will be searched for all relevant primary and secondary studies, grey literature, and other sources concerning the type of acupressure interventions and the effectiveness of acupressure on anxiety. The sources retrieved will be independently assessed by two reviewers utilising the eligibility criteria defined by the population concept and context (PCC) framework. A PRISMA-ScR flowchart will be applied to track the number of identified, included, and excluded sources. Extracted data and variables will be presented in a data extraction table. Narrative explanations will accompany the synthesised results. Conclusions: The review’s findings can assist in identifying priorities for future research and provide recommendations for optimal protocols for clinical implementation.
Adrián Lescano, Nicolás Atamañuk, Guillermo Bortman, Jorge Cáneva, Mirta Diez, Guillermo Giacomi, Luís Lema, Eduardo R. Perna
International Journal of Clinical Trials, Volume 9, pp 174-182;

Background: Pulmonary hypertension (PH) is a chronic, progressive condition with high morbidity and mortality due to right heart (RH) failure. Prognosis depends on RH adaptability and remodelling in response to increased pulmonary arterial pressure. There is little information regarding risk variables and prognostic factors in the Argentinian population, current risk scores have not been validated, and its impact on free-event survival is still unknown. Prostacyclin analogues are the first-line treatment for high-risk patients. However, there is limited evidence on its clinical benefits, long-term effects, and impact on RH remodelling in the Argentinian population. Methods: The study was designed as a national, multicentre, prospective, observational, phase IV study including 100 patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, treated with subcutaneous treprostinil and followed up for 48 months. The study will be conducted in parallel with the patients' standard management and treatment in each centre. The primary objective is to assess the long-term improvement or reversal of RH remodelling (RHRR) parameters obtained by echocardiography. Secondary objectives include the evaluation of the prognostic value of RHRR parameters and the rate of clinical events, the treatment effect in terms of pulmonary vascular resistance, right ventricle systolic function, morbidity and all-cause mortality, quality of life, and safety and tolerability. Conclusions: This study will help to determine the clinical benefits, long-term effects, and impact on RH remodelling of prostacyclin analogues in Argentina. Trial registration: The trial was registered at Registro Nacional de Investigaciones en Salud (RENIS) in Argentina (; registration number IS003303).
Vaia Sapouna, Zacharias Dimitriadis, Konstantinos Douros, Eleni Kapreli, Eleni Kortianou
International Journal of Clinical Trials, Volume 9, pp 205-210;

Background: Optimal adherence to pharmacological and non-pharmacological treatment in pediatric pulmonary diseases is crucial to address the increased morbidity levels. The purpose of this scoping review was to investigate the level of evidence about technical factors that facilitate adherence to non-pharmacological treatment with the use of mobile health (mHealth) in children with chronic respiratory diseases. Methods: The methodological framework for scoping review recommended by Arksey and O’Malley’s and Levac will be followed for conducting the present one. The preferred reporting items for systematic reviews and meta-analyses for scoping reviews (PRISMA-ScR) guidelines will be used. Methodological quality will be assessed using the critical appraisal skills programme (CASP) checklist and the mixed methods appraisal tool (MMAT). Five databases will be searched: Medline (via Ovid), PubMed, Scopus, CINAHL (EBSCOhost) and Cochrane Library. Two independent reviewers will screen titles and abstracts for assessment against the eligibility criteria. Any disagreements will be resolved through discussion and consensus among other authors. Data will be extracted and presented in a narrative summary. Conclusions: This scoping review does not require ethics approval as it only includes information from previously published studies. The results will be disseminated through a peer-review publication, conference presentations and/or as part of stakeholder meetings with physiotherapists, clinicians, academicians, technicians and researchers. Trial Registration: NA.
, Aysel Gurkan
International Journal of Clinical Trials, Volume 9, pp 197-204;

Background: Pain, anxiety, and sleep disorders are common side effects of coronary artery bypass graft (CABG) surgery. Although pharmacological agents are currently used in the treatment of these problems, in addition to their undesirable side effects, they increase healthcare costs, and their inadequate control leads to morbidities, prolonged hospital stay and increased burden of care. Therefore, supportive interventions are needed. The aim of this study is to determine the effect of lavender oil inhalation on the pain intensity, anxiety and sleep quality of patients that underwent CABG surgery. Methods: This study was planned as a prospective randomized controlled trial. Participants meeting the inclusion criteria will be randomly assigned to the intervention and control groups. During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day, while the control group will only receive routine care. The pain intensity of the groups will be evaluated with the numeric rating scale, anxiety levels with the state-trait anxiety inventory, and sleep quality with the Richards-Campbell sleep questionnaire. Conclusions: There is a need for new approaches to improve the physiological and psychological health of patients after CABG surgery and help them return to their daily life activities and social lives in a shorter time. This trial will allow for the assessment of the effects of this intervention and provide valuable evidence to guide clinical practice. Trial registration: This trial was registered in May, 2022 (NCT05377983).
Hyunjin Park, Zac Morse
International Journal of Clinical Trials, Volume 9, pp 183-186;

Background: Removable orthodontic treatment corrects dental and skeletal malocclusion by utilising various types of removable appliances. Although removable orthodontic treatment has a reduced risk of dental caries compared to fixed orthodontic treatment, removable appliances create niches for cariogenic microorganisms to increase their numbers and lead to an ecological shift. However, there is insufficient information on caries prevention during removable orthodontic treatment. The protocol details the research for a scoping review of caries prevention during removable orthodontic treatment. Methods: This scoping review will be conducted according to the Preferred Reporting Items for Systemic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) Manual for Evidence Synthesis guidelines. Published primary and secondary research studies (including reviews), guidelines, websites, and reports that are written in English until April 2022 will be searched from seven databases, including Dentistry and Oral Sciences Source, CINAHL, MEDLINE, via EBSCOHost, Scopus, Cochrane, Google, and Google Scholar. Two reviewers (HP and ZM) will analyse the retrieved articles simultaneously using the parameters and three-step strategy recommended by JBI. Obtained numbers of included and excluded identified sources will be presented in a PRISMA flow diagram and the data extraction table will demonstrate the variables from included sources. Conclusions: The findings of this review will be summarised in a narrative description to facilitate guidance in clinical practice and research for health professionals.
Ashley S. Bae
International Journal of Clinical Trials, Volume 9, pp 227-233;

Despite the United States’ (U.S.) longstanding history of promoting a melting pot nation of people from diverse racial and ethnic backgrounds all capable of achieving the American Dream, it is argued that the U.S. is failing to deliver high quality healthcare to all of its constituents equally. The widely seen health disparities of ethnic minority groups endure has extended into the parallel field of clinical research and clinical trials. There is a staggering gap between the percentage of White clinical trial participants compared to clinical trial participants of racially and ethnically diverse minority groups in U.S. clinical trials. Underrepresentation of minority groups in clinical trials dismisses opportunities to identify potential serious sub-group safety or efficacy signals, open doors to access life-saving treatments, and ultimately improve the standard of evidence-based medicine in the United States. Current literature on this issue frequently reiterates the following five key barriers underrepresented minority groups face against clinical trial participation: mistrust, lack of awareness and access, cultural and language barriers, investigator and provider bias, and financial burdens. A deeper dive into understanding each barrier will be critical in implementing changes with actions and in perspectives in order to address the issue of poor racial and ethnic representation in clinical trial populations.
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