Clinical trials

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.

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.

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 \>=5) at 18 months among patients who remitted (PHQ-9\<5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption/uptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.

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.

Antibiotics are a mainstay of the treatment of lower respiratory infections in young children even though most episodes are caused by self-limiting viruses. Innovative child friendly tools that improve the diagnosis of respiratory illnesses, safely reduce the unnecessary use of antibiotics, and are suitable for implementation in resource-constrained settings are urgently required to safely improve antibiotic stewardship and stem the rising rates of antibiotic resistance globally. In the Bangladesh Lung Auscultation Artificial Intelligence for Antibiotic Stewardship Trial (BLAAAST) the investigators aim to determine whether treatment failure frequency among children in rural Bangladesh managed by clinical guidelines enhanced by a commercially available, artificial intelligence (AI)-enabled digital stethoscope is non-inferior to guidelines alone. The investigators hypothesize treatment failure frequency among 'enhanced IMCI' participants will be no worse than standard care by a +/-2% margin, safely reducing antibiotic use by 50-60%. The investigators will also evaluate if a diagnostic strategy enhanced by an AI-enabled digital stethoscope is a sustainable alternative to standard care for children in rural Bangladesh. The investigators hypothesize that care augmented by an AI-enabled digital stethoscope will have additional benefits via reduced antibiotic use that will outweigh digital auscultation costs resulting in cost-effectiveness compared to current practice. BLAAAST affords a unique opportunity to evaluate the efficacy of clinical guidelines enhanced by an AI-enabled digital stethoscope on child pneumonia outcomes in Bangladesh, if digital auscultation may be instrumental in the wider antibiotic stewardship strategy, and whether a digital stethoscope diagnostic tool is cost-effective in the care of children with respiratory illnesses.

The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40/41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40/41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.

This study aims to examine the effects of Emotional Intelligence (EI) training on marital satisfaction and mental health among married adults in Dhaka city, Bangladesh. Emotional intelligence refers to the ability to recognize, understand, regulate, and manage emotions in oneself and others. Previous studies suggest that emotional intelligence is associated with better relationship quality and psychological well-being; however, limited intervention-based evidence is available in Bangladesh. A pretest-posttest quasi-experimental design with intervention and control groups will be used. Married adults living in Dhaka City will be assessed on emotional intelligence, marital satisfaction, anxiety, depression, and mental well-being at baseline. Participants with lower emotional intelligence scores based on the baseline TEIQue-SF assessment will be selected for the intervention phase. The intervention group will receive a structured emotional intelligence training program focusing on emotional awareness, emotion regulation, empathy, communication skills, and interpersonal problem-solving. Assessments will be conducted at baseline, post-intervention, and follow-up to evaluate changes in marital satisfaction and mental health outcomes. The findings are expected to provide evidence regarding the effectiveness of emotional intelligence training as a low-cost, non-clinical intervention for improving marital relationships and psychological well-being among married individuals in Bangladesh.

Chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM) is a major cause of morbidity, commonly associated with persistent albuminuria and progressive renal decline. Reducing albuminuria is a key therapeutic goal to slow disease progression. Sodium-glucose cotransporter-2 inhibitors like dapagliflozin and non-steroidal mineralocorticoid receptor antagonists such as finerenone have independently shown significant renoprotective effects. Their combined use may provide additive benefits. This open-label randomized controlled trial will be conducted in the Department of Nephrology, Chittagong Medical College Hospital, Bangladesh, including 88 patients with CKD and T2DM. Participants will be randomized into two groups: one receiving dapagliflozin 10 mg plus finerenone 10 mg daily, and the other receiving dapagliflozin 10 mg alone for eight weeks. The primary outcome will be the change in urinary albumin-to-creatinine ratio (UACR). Secondary outcomes include serum creatinine, estimated glomerular filtration rate (eGFR), and serum potassium. Safety and adverse events will also be monitored. Data will be analyzed using SPSS version 27. This study aims to assess whether combination therapy is more effective than dapagliflozin alone in reducing albuminuria and may help guide treatment strategies in diabetic CKD.

The present study examined the effects of an emotional intelligence (EI)-based training program on emotional intelligence and mental health outcomes among secondary school teachers and students in Dhaka City, Bangladesh. The study addressed whether the EI-based intervention improves emotional intelligence and reduces psychological distress, including anxiety and depression, while enhancing overall wellbeing (emotional, social, and psychological). A quasi-experimental design was employed, comparing participants who received a structured EI training program with a control group. The intervention was based on Goleman's mixed model of emotional intelligence, focusing on four core domains: self-awareness, self-management, social awareness, and relationship management. Participants were assessed at multiple time points using standardized measures of emotional intelligence, anxiety, depression, and mental health continuum. The study also incorporated a follow-up assessment to examine outcomes over time. The findings aim to contribute to understanding the role of emotional intelligence in promoting mental health and to inform school-based psychological intervention strategies.

The goal of this clinical trial (cluster randomized controlled trial) is to learn whether a Positive Deviance/Hearth (PDH) intervention can effectively treat moderate acute malnutrition (MAM) and reduce relapse compared to standard care in children aged 6-59 months diagnosed with MAM in Bangladesh. The main questions it aims to answer are: * Does the PDH intervention improve recovery rates among children with MAM? * Does the PDH intervention reduce relapse to MAM or progression to severe acute malnutrition (SAM) after recovery? Researchers will compare communities receiving the PDH intervention to communities receiving standard nutrition care (e.g., usual counseling or supplementary feeding programs) to see if PDH leads to better nutritional recovery and sustained outcomes. Participants will: * Take part in a 12-day "Hearth" nutrition education program where caregivers prepare and feed children nutrient-dense meals using local foods * Receive 2 weeks of home follow-up visits by volunteers after the Hearth sessions, along with ongoing growth monitoring and counseling twice per month * Undergo periodic anthropometric assessments (weight, height/length, Mid-upper arm circumference (MUAC)) at key time points

The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are: Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only. Participants will: Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.

The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are: Does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only. Participants will: Take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.

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.

This study examines how seafood consumption, social changes, and climate change affect the nutrition and well-being of adolescent girls in south-western Bangladesh. Many adolescent girls face poor nutrition, early marriage, and limited access to adequate diets. Adolescent girls have high nutritional needs due to growth and potential early motherhood. Seafood, including fish, shrimp, and prawns, provides important nutrients such as omega-3 fatty acids, but little is known about how its consumption relates to nutritional status in this population. The study will collect new data from adolescent girls in the same area as a 2017 study (IMMANA study), assessing dietary pattern, nutritional status, socioeconomic conditions, and female autonomy. It will also explore how climate change affects household food access and nutrition to provide policies linking food systems and public health.

This study aims to examine how societal and climate changes influence the nutritional status and fish consumption of young women over a 10 year period in southern Bangladesh, and how these factors affect their children's health. A cohort of 240 adolescents first studied in 2017 will be followed to assess changes in their dietary patterns, nutritional status, climate perceptions and mitigation practices, as well as the nutritional status of their children aged 6 months to 5 years. The study in 2017 sampled 60 adolescent girls in each of four rural communities, plus a semi-rural community around a fish processing plant, representing in total 5 communities. Of these 60 X 5 = 300 girls, the current study follows up the individuals in the rural communities representing a cohort of 240. Bangladesh faces high rates of adolescent malnutrition, with many girls married before 18 and suffering from chronic nutrient deficiencies. These issues have long-term impacts on health, productivity, and intergenerational well-being. By linking the fisheries and aquaculture sector, a key to Bangladesh's economy with public health and nutrition, this research aims to guide targeted policies for vulnerable coastal communities.

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures worldwide. Although the widespread implementation of Enhanced Recovery after Surgery (ERAS) protocols has improved perioperative outcomes, many patients continue to experience postoperative pain, sleep disturbance, anxiety, nausea, and fatigue, symptoms that collectively impair overall quality of recovery (QoR). Melatonin, an endogenous hormone that regulates circadian rhythm, also possesses anxiolytic, analgesic, antioxidant, and anti-inflammatory properties, positioning it as a valuable perioperative adjunct. However, most previous studies have evaluated melatonin primarily for isolated outcomes such as sleep quality or anxiety. Its effect on comprehensive postoperative recovery, assessed using validated patient-reported outcome instruments, remains insufficiently explored, particularly in laparoscopic cholecystectomy populations and in South Asian clinical settings. This prospective, randomized, double-blind, placebo-controlled trial (the MEL-REC trial) aims to evaluate the effect of preoperative oral melatonin on postoperative quality of recovery in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study will be conducted in the Department of Anaesthesiology at Combined Military Hospital (CMH), Dhaka, Bangladesh, over a total study period of 18 months (January 2026 to June 2027), with patient recruitment planned for 8 months (May to December 2026) after taking approval from institutional review board. Eighty four adult patients aged 18-60 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly allocated in a 1:1 ratio into two equal groups (n = 42 per group) using computer-generated permuted block randomization with centralized pharmacy based allocation concealment. The melatonin group (Group M) will receive oral melatonin 6 mg administered 60 minutes before induction of anaesthesia and the placebo group (Group P) will receive an identical placebo tablet under the same conditions. Neither the participants, the treating anaesthesiologist, the outcome assessor, nor the data analyst will be aware of group allocation until database lock. All patients will receive a standardized anaesthesia and perioperative management protocol, including standardized postoperative analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) score at 24 ± 2 hours after surgery. Secondary outcomes include postoperative sleep quality measured by the Richards-Campbell Sleep Questionnaire, change in preoperative anxiety (delta-VAS-A score), total opioid consumption during the first 24 hours expressed as intravenous morphine milligram equivalents, incidence of postoperative nausea and vomiting, and time to first rescue analgesic request. All postoperative outcomes will be assessed by a trained research assistant blinded to group allocation. Based on the available evidence, it is anticipated that patients receiving preoperative melatonin will demonstrate higher QoR-15 scores at 24 hours after surgery compared with the placebo group. The melatonin group is also expected to have improved postoperative sleep quality, reduced opioid consumption, and a greater reduction in preoperative anxiety. If a clinically meaningful benefit is confirmed, given its well established safety profile, low cost, and ease of oral administration, preoperative melatonin may represent a practical perioperative adjunct that can be readily incorporated into ERAS protocols for laparoscopic cholecystectomy. The trial will be prospectively registered in the Bangladesh Medical Research Council (BMRC) clinical trial registry or clinicaltrials.gov prior to recruitment.

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 communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. 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.

The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are: * Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP? * Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP. * Does STOPS training improve the quality of care among Bangladeshi physiotherapists?

This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery. Patients will be randomly assigned to one of two groups: Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia. The main goals are to determine: How much pain relief each method provides, measured using a visual analog scale (VAS). The total amount of opioids required during the first 24 hours post-surgery. Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels. This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery

The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia. The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen. Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication. Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days. Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication. Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up. Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.

The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.

Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers. This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and \~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials). The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.