There are about 620 clinical studies being (or have been) conducted in Bangladesh. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Globally, non-communicable diseases (NCDs) are the leading cause of both mortality and morbidity. This intervention study aims to prevent and manage NCDs by adopting the World Health Organization's (WHO) comprehensive 'whole-of-government' and 'whole-of-society' approach. Although the Bangladesh government has devised a Multisectoral Action Plan (MAP) for NCD prevention and control, there's a need to operationalize these approaches at the sub-district level. This requires establishing a framework, implementing it, and assessing its effectiveness. To accomplish the study's objectives, the investigators will initially identify key stakeholders involved in NCD-related work or potentially able to contribute. Subsequently, investigators will qualitatively explore their potential involvement in NCD prevention and control, including their current roles and responsibilities, and how they could further contribute. Workshops will be conducted with these stakeholders to develop a tailored intervention model for NCD prevention and control at the sub-district level, utilizing the 'whole-of-government' and 'whole-of-society' approach. Following this, the sub-district specific model will be implemented, and the process will be documented. Finally, an evaluation will be conducted to assess the effectiveness of the sub-district specific model in achieving NCD-specific outcomes.
The study titled "Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh" aims to assess the real-world effectiveness and safety of omarigliptin in managing newly diagnosed type 2 diabetes mellitus (T2DM) patients. Conducted at BIRDEM General Hospital, this 12-month observational study involves 938 patients aged 18 years or older, newly diagnosed with T2DM, with no prior use of antidiabetic medications. T2DM is a growing global health concern, necessitating effective treatment strategies. Omarigliptin, a once-weekly DPP-4 inhibitor, has shown promising results in clinical trials worldwide. However, its real-world efficacy and safety in diverse populations like Bangladesh remain under-explored. This study aims to fill this gap by evaluating omarigliptin in a typical clinical setting in Bangladesh, potentially providing valuable insights for healthcare providers. Study Objectives: To assess the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM. Specific objectives include evaluating glycemic control (HbA1C levels), safety regarding adverse events, and other outcomes such as changes in fasting plasma glucose, electrolyte levels, liver enzymes, creatinine, and lipid profile. Methodology: Conducted in the Department of Endocrinology at BIRDEM General Hospital over 12 months, the study population includes newly diagnosed T2DM patients divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents. Sample size calculation determined 469 patients per group, accounting for a 15% dropout rate. Inclusion Criteria: - Newly diagnosed T2DM (according to ADA guidelines) aged ≥ 18 years - HbA1C levels between ≥7.0% and ≤10.0% - Stable doses of antidiabetic drugs for at least 4 weeks Exclusion Criteria: - Prescribed insulin for diabetes management - Significant weight loss, hypersensitivity to antidiabetic drugs, type 1 diabetes, ketoacidosis, active liver disease, significant cardiovascular disease, malignancy, hematological disorders, pregnancy, and severe renal impairment, among others. Study Variables: Data will be collected on demographic variables (age, gender, socio-economic status, BMI), laboratory variables (HbA1C, fasting blood glucose, lipid profile, creatinine, electrolytes, ALT, and postprandial glucose), and adverse events (respiratory infections, headaches, gastrointestinal issues, joint pain). Study Procedure: Patients will receive personalized antidiabetic treatment with or without omarigliptin, alongside standard dietary and exercise recommendations. Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. Data will be collected through interviews, physical exams, and laboratory tests, recorded in case record forms (CRFs). Adverse Event Monitoring: Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will be instructed to record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability. Data Analysis: Data will be analyzed using SPSS Version 23. Descriptive analyses will investigate participant characteristics, with statistical significance set at p < 0.05. Parametric variables will be assessed using Student's t-test, and Spearman's correlation will be used for correlations. Regression analyses will also be performed. Ethical Considerations: The study will adhere to the Declaration of Helsinki and other ethical guidelines. Approval will be sought from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.
This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients
Background: Diabetes is a growing public health concern in Bangladesh, with millions affected. Diabetic Kidney Disease (DKD) is a severe complication of diabetes, affecting approximately 21.3% of the diabetic population. To address this issue, a comprehensive assessment of DKD within the Bangladesh Diabetic Association's (BADAS) affiliated healthcare centres is necessary. Objective: The study's general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers. Specific objectives include assessing risk factors, screening practices, disease staging, management approaches, patient education, and providing evidence-based recommendations. Methodology: - Study Design: Cross-sectional - Study Population: All diabetic patients at BADAS-affiliated centers - Exclusion Criteria: Patients unwilling to participate or with kidney disease from other causes and with acute illness - Sample Size: "Forty patients will be selected from each center, resulting in a total sample size of 320 patients across eight centers, with one center randomly selected from each of the eight divisions in Bangladesh." - Data Collection: Demographics, comorbidities, kidney function, blood pressure, HbA1c levels, medication records, treatment guideline adherence - Data Analysis: prevalence of diabetic kidney disease, factors affecting management, and potential barriers - Ethical Considerations: Ensure patient data privacy, obtain approvals, and informed consent Implications: The study aims to provide insights into the current state of magnitude (prevalence) of DKD, its management, highlighting areas for improvement in patient care, guideline adherence, and ultimately enhancing the well-being of diabetic patients in Bangladesh.
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV. SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens. Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.
Status epilepticus (SE) is an emergency, life-threatening medical condition that may cause irreversible cerebral damage. Therefore, the rapid and secure cessation of seizures and resuscitation is crucial. Potent gamma-aminobutyric acid agonists, including benzodiazepines, are recommended as first-line treatments. For the complete cessation of SE and prevention of recurrence, long-acting antiepileptic drugs (e.g.- FPHT) are also required as second-line treatments along with short-acting benzodiazepines. Intravenous fosphenytoin (FPHT) is associated with fewer adverse events such as life-threatening arrhythmia, cardiac arrest, hypotension, and allergic reactions. Levetiracetam (LEV), is considered to be effective for SE with less serious adverse events including dizziness, somnolence, headache, and transient agitation, but there have been no reports of arrhythmias, hypotension, Stevens-Johnson syndrome, or hepatotoxicity. Preceding studies show that levetiracetam is similarly effective and associated with fewer adverse effects than those of fosphenytoin. Few trials have compared the effectiveness and safety of levetiracetam (LEV) and fosphenytoin (FHP) for status epilepticus worldwide. Moreover, genetic variation is likely to play a crucial role in the development of adverse drug reactions (ADRs) including drug resistance. By far, no study has yet been conducted addressing the issue of efficacy and safety between levetiracetam (LEV) and fosphenytoin (FHP) in status epilepticus in the context of the Bangladeshi population. A comparative study of the efficacy and safety of levetiracetam (LEV) and fosphenytoin (FHP) will be expected to give more confidence for the use of the drug. Considering this the study aims to assess the safety and efficacy of levetiracetam (LEV) and fosphenytoin (FHP) in status epilepticus. This study finding has an implication in the treatment protocol which will be beneficial for the patients and physicians as well. Furthermore, it will give input to the policymaker for developing new guidelines regarding status epilepticus management and also encourage future research.
Background: Historically, acetabular fractures were treated conservatively which leading to long lasting morbidity like severe pain, limitation of movement and osteoarthritis. Now, evidence suggest surgery for all acetabular fractures for better outcome. Objectives: To evaluate the clinical and functional outcomes of open reduction and internal fixation of posterior wall of acetabulum fractures. Methods: This prospective clinical trial was conducted at Chittagong Medical College hospital, Chattogram, from January 2022 to February 2024. Sample size was 32 with fractures as per set criteria and was treated surgically. The outcome variables were functional (according to modified Merle D'Aubigne and Postel score) and radiological (according to Matta's grading). Evaluation was done at 6th weeks and at 03rd, 06th, 09th months. Detailed history, clinical examination, investigations, operative details, post-operative outcome and other parameters were documented. Data were collected in data collection form and were analyzed at the end of the study by using SPSS-25. P-value was considered as statistically significant when it was less than 0.05 and confidence interval was set at 95% level.
This school-based cluster randomized controlled trial aims to assess the feasibility of implementing the Adolescent Tobacco Initiation Prevention (IATIP) and evaluate the potential efficacy of IATIP in preventing tobacco initiation and promoting the health and well-being of school adolescents in Dhaka, Bangladesh. The intervention consists of three 40-minute sessions, delivered over three successive days, including knowledge and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion.
Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) [1]. One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes [2]. In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease [3]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers [4]. However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm.
This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.