Clinical trials

This study will evaluate the efficacy and safety of low-dose duloxetine combined with alpha-lipoic acid compared with standard-dose duloxetine in adults with painful diabetic peripheral neuropathy. In this assessor-blinded, randomized, parallel-arm, non-inferiority trial, participants will be assigned in a 1:1 ratio to receive either duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily or duloxetine 60 mg once daily. The primary outcome will be the change in pain intensity measured by the Numerical Rating Scale from baseline to Week 9. Secondary outcomes will include changes in pain intensity at Week 5, Patient Global Impression of Change at Weeks 5 and 9, the proportion of participants achieving at least a 30% reduction in pain intensity, adverse effects, treatment tolerability and treatment compliance.

This study is testing whether a medicine called mycophenolate mofetil (MMF) works better than the usual treatment for people whose kidney disease, called IgA nephropathy, has not improved with standard care. IgA nephropathy is a kidney disease that can cause protein to leak into the urine and, over time, can damage the kidneys. Some people with this disease do not get better even after standard treatment. Doctors call this "refractory" disease. Right now, there is no proven best treatment for these patients in Bangladesh. This study will include 116 adults with kidney disease that has been confirmed by a kidney tissue sample and has not improved with standard treatment. Participants will be split into two equal groups by chance, like a coin flip. One group will take MMF by mouth for 6 months, along with the usual supportive care. The other group will take a steroid medicine called prednisolone, along with the usual supportive care. Both groups will also continue treatments like blood pressure medicines that are already part of standard care for this condition. Researchers want to find out how many people in each group get better, meaning their urine protein drops to a low level and their kidney function stays stable. They will also look at changes in kidney function and any side effects from the medicines. The study will take place at the National Institute of Kidney Diseases and Urology Hospital in Dhaka, Bangladesh, over about one year. Each participant will be followed for 6 months, with check-up visits and blood and urine tests at the start, at 3 months, and at 6 months.

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.

The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are: Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population? Does initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels? Participants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.

The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.

The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are: Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University? Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit. Participants will: Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session

The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are: Is robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training? The Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery. Participants will: Receive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training

The goal of this clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use. The main questions it aims to answer are: Is training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone? Researchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit. Participants will: Be adults aged 18-60 with arm and/or leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of NVTIA® Ergothioneine, a branded ergothioneine ingredient, on healthy aging biomarkers and skin health in healthy adults aged 40 to 65 years. Participants will receive either NVTIA® Ergothioneine or a matching placebo once daily for 12 weeks. The primary objective of this study is to evaluate the effects of NVTIA® Ergothioneine supplementation on biomarkers associated with oxidative stress and healthy aging. Secondary objectives include assessment of skin elasticity, skin hydration, inflammatory biomarkers, and overall safety. The findings of this study are expected to provide clinical evidence supporting the role of NVTIA® Ergothioneine in promoting healthy aging and maintaining skin health.

MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) formulation and to test an enhanced regimen (MMS+) with additional nutrients, vs. weekly iron-folic acid as standard of care on outcomes of neurodevelopment, linear growth, biochemical status, bone health, and other functional and health outcomes. This study is an individually randomized, open-label, three-arm trial of 3,000 participants supplemented for 12 months to assess the efficacy and safety of nutrient supplementation. Results of the study will inform the design of nutritional interventions and policy for this age group. In the context of the trial, the investigators will also do in-depth clinical and health assessments and collect biospecimens for a bio-archive for future deep-phenotyping of this population. This study will be conducted at the Johns Hopkins Bangladesh JiVitA field site in rural Gaibandha District of Bangladesh.

Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage. This study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity. Abdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool/ rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.

This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. All participants will receive the same number of injections and will be randomly assigned to receive one of the followings: * Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125). * Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125) * Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125) Clinical procedure for participants: * Standardized symptom questionnaire * Physical examination: Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential) * Venous blood collection (Pre-vaccination) 3mL * Vaccination

Gender and sexual minority adults in Bangladesh experience high levels of stigma-related stress. Acute stress can trigger strong, affect-driven urges to smoke, vape, or engage in stress-attributed eating. These urges can rise and fall within minutes to hours, operating outside the reach of conventional clinic-based interventions delivered days or weeks later. This pilot micro-randomized trial (MRT) evaluates whether delivering a brief, culturally adapted support message via smartphone during moments of high self-reported stress reduces the intensity of the urge for the participant's pre-specified target behaviour, relative to no message. Over a 24-day period, 115 participants will be scheduled for up to 5 ecological momentary assessments (EMA) per day. Whenever a participant reports an acute stress level of 5 or higher (0 to 10 scale) and satisfies pre-specified privacy, safety, behavioural, and spacing criteria, the app randomizes with probability 0.5 to deliver either a brief support message or no message. By contributing multiple randomized decision points over time, each participant serves as their own micro-control. The primary outcome is the intensity of the urge for the participant's pre-specified target behaviour, measured 45 to 60 minutes after randomization. An exploratory urge assessment is also collected 10 minutes after randomization; comparing the two time points will help establish whether the support message's effect is immediate, delayed, or both, and will inform the choice of follow-up window for a future, fully powered trial. Prior to trial launch, all EMA items, message content, notification logic, and digital safety protocols will be developed and tested with community members, reviewed by a Community Advisory Board, and locked. As a pilot optimization trial, its objectives are to estimate the short-term causal effect of the prompt, to identify the contexts in which that effect is larger or smaller, and to establish whether momentary assessment and just-in-time intervention research can be delivered safely, privately, and acceptably in this high-stigma setting. The study does not evaluate long-term behavioural maintenance and does not claim to address the underlying structural stigma and discrimination that produce minority stress.

The goal of this pilot randomized controlled trial is to learn whether the ZEPU-SG1PLUS Hand Functional Comprehensive Training System - a robotic device used alongside standard rehabilitation - is safe, feasible, and helpful for people with upper limb (arm/hand) motor problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions. The main questions it aims to answer are: Is robotic-assisted hand training well tolerated by patients, and can it be safely added to standard rehabilitation, with acceptable rates of device-related side effects? Does adding robotic hand training to standard rehabilitation improve arm and hand strength, range of motion, and functional ability compared with standard rehabilitation alone? Is it practical to fit this type of robotic training into everyday rehabilitation services at Bangladesh Medical University? Researchers will compare a robotic-augmented rehabilitation group to a standard-care (control) group to see whether adding robotic hand training works better than usual rehabilitation alone. Participants will: Be randomly assigned to one of two groups: one receiving standard rehabilitation plus robotic hand training with the ZEPU-SG1PLUS device, and one receiving standard rehabilitation alone If assigned to the robotic training group, attend three training sessions per week for 12 weeks, each lasting about 30-45 minutes, at the Robotic Rehabilitation Centre, BMU Undergo assessments at the start of the study and at two-week intervals during the 12-week program and follow-up period, including tests of muscle strength, joint movement, hand function, and daily activity ability Be monitored throughout for any side effects or safety concerns related to the training

The goal of this clinical trial is to learn if robot-assisted lower-limb strength and gait training can improve safety, feasibility, and functional recovery in adults aged 18-60 years with lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, or persistent gait impairment following orthopedic surgery. The main questions it aims to answer are: Is robot-assisted training using the ZEPU-AI5 device safe and well-tolerated, with an acceptable rate of device-related adverse events? Does adding ZEPU-AI5-assisted training to standard-of-care rehabilitation improve functional outcomes (such as walking distance, muscle strength, balance, and mobility) compared to standard-of-care rehabilitation alone? Researchers will compare an intervention group receiving standard-of-care rehabilitation combined with ZEPU-AI5-assisted training to a control group receiving standard-of-care rehabilitation alone, to see if the addition of robotic training leads to greater improvements in safety, functional recovery, and quality of life. Participants will: Undergo a baseline assessment before starting the study Receive either robot-assisted training plus standard-of-care rehabilitation, or standard-of-care rehabilitation alone, three times per week for 12 weeks Complete follow-up assessments every two weeks to evaluate safety, functional outcomes, and durability of any benefits

Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh. This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone. Thirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period. The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.

Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.

Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population. This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.

Functional dyspepsia (FD) is a common gastrointestinal disorder with an important impact on quality of life. There is a paucity of updated data on the prevalence of FD in rural areas of Bangladesh. The present study will be carried out to find the prevalence of FD in a community in rural Bangladesh. It also assesses potential risk factors. Eligible participants will first be evaluated for symptoms by a clinical interview using the standardized Rome IV functional dyspepsia questionnaire. Those who meet Rome IV criteria will then have an upper gastrointestinal endoscopy to exclude underlying organic diseases to establish a definitive diagnosis. Eventually patients with normal endoscopic findings will be diagnosed as having functional dyspepsia. This allows the accurate calculation of disease prevalence. Researchers will gather demographic information, lifestyle habits, and dietary patterns. The results will give important baseline data on rural FD burdens. Such data can inform community health care interventions.

To evaluate the effectiveness of the CATI approach among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city, cholera cases will be enrolled by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka hospital. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The 'Case area targeted interventions' (CATI) will be given by administrating Oral Cholera Vaccine (OCV) with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The passive surveillance for cholera will be followed using the icddr,b hospital, and other health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.

The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism. It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (\<140/90mmHg) and unsuppressed plasma renin concentration (\>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.

The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors? Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention. This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.

CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \[\<1 hour\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg/kg dose of oral caffeine followed by two additional 10 mg/kg doses at 24-hour intervals or placebo of the same regimen (three total doses). The goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.

Migraine is a common and disabling neurological condition that affects quality of life, work productivity, and daily functioning. In Bangladesh, migraine is a major health problem, yet access to effective and affordable preventive treatments remains limited. Preventive (prophylactic) treatment is recommended for people who experience frequent migraine attacks in order to reduce the number, severity, and duration of headaches. Propranolol and flunarizine are two commonly used and relatively inexpensive medications for migraine prevention. Both drugs have been shown to reduce migraine frequency when used alone. However, some patients do not respond adequately to a single medication. Using a combination of drugs that work through different mechanisms may improve treatment effectiveness without significantly increasing side effects. There is limited local evidence comparing propranolol, flunarizine, and their combination in migraine prevention, particularly in the Bangladeshi population. This study is designed to compare the effectiveness and safety of propranolol alone, flunarizine alone, and a combination of propranolol and flunarizine in preventing episodic migraine in adults. The main hypothesis is that at least one of these treatment strategies, particularly combination therapy, may be more effective than the others in reducing migraine burden. This is an open-label, parallel-arm, randomized controlled trial conducted at Chittagong Medical College Hospital, Bangladesh. A total of 177 adult patients aged 18 to 55 years who are diagnosed with episodic migraine and experience four or more migraine attacks per month will be enrolled. Participants will be randomly assigned to one of three treatment groups: propranolol, flunarizine, or a combination of both medications. Treatment will be given for 12 weeks, with dose adjustments during the first week and follow-up visits at 6 and 12 weeks. The primary outcome of the study is the reduction in the number of monthly migraine days. Secondary outcomes include the proportion of patients achieving at least a 50% reduction in migraine days, changes in headache severity and duration, improvement in migraine-related disability (measured by the Migraine Disability Assessment Score), patient-reported treatment satisfaction, and the frequency of side effects. The results of this study are expected to provide important local evidence to guide clinicians in selecting effective and affordable migraine preventive treatments and to clarify whether combination therapy offers additional benefits over single-drug therapy in routine clinical practice.

The goal of this clinical trial is to determine whether Neurolytic Splanchnic Nerve Block (NSNB) reduces pain in adults with upper abdominal malignancies. It will also evaluate the safety of Neurolytic Splanchnic Nerve Block (NSNB). The main questions it aims to answer are: Does NSNB reduce pain intensity compared to Neurolytic Coeliac Plexus Block (NCPB), as measured by the Visual Analog Scale (VAS)? What adverse effects do participants experience when receiving Neurolytic Splanchnic Nerve Block (NSNB)? Investigators will compare Neurolytic Splanchnic Nerve Block (NSNB) with Neurolytic Coeliac Plexus Block (NCPB) to determine which intervention provides more effective and safer pain relief. Participants will: * receive either NSNB or NCPB under fluoroscopic guidance * be monitored immediately and for 2 hours after the procedure for any complications Have their pain intensity recorded immediately after the procedure, and at 7 days, 1 month, and 3 months * be evaluated for quality-of-life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 3 (EORTC QLQ-C30) at 1 month and 3 months. * have their opioid consumption tracked throughout the study.