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, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates. Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.
This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person.
In the present implementation study, we aim to document the experience of implementing integrated, decentralized primary care in rural Bangladesh, including components of healthcare provider training, mHealth, decentralization with task shifting, and community-based care, and to generate data on the effectiveness and cost-effectiveness of the multicomponent integrated care as compared to usual care and to mHealth intervention alone. We will also Investigate the factors that explain how the interventions influence hypertension and diabetes management and explore barriers/facilitators to delivering and sustaining intervention. We will conduct mixed-methods research to understand how the intervention influences treatment and prevention in this patient population. Particularly, we will assess lifestyle changes (i.e., smoking, dietary salt intake, physical activity, alcohol consumption), and burden for patients (e.g., waiting time, travel-related cost) at individual and community level. Qualitative data will shed light on facilitators and barriers to hypertension and diabetes prevention and control from the perspectives of patients (and their families), primary care providers, public health officials, and other stakeholders. Additionally, we will undertake a health economic evaluation of the interventions for primary care systems. A comprehensive evaluation of cost and effectiveness will be important for the models tested, providing necessary evidence for policymakers and stakeholders to scale up the interventions. We hypothesize that compared with usual care, the multicomponent decentralized primary care will improve all steps along hypertension and diabetes care continuum. On the other hand, we hypothesize that the mHealth intervention alone (Simple App) may improve BP and glycemic control compared with usual care but will have a limited impact on rates of screening, diagnosis, and treatment. We also hypothesize that the multicomponent integrated care will lead to a higher treatment success rate relative to mHealth intervention alone.
The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not. Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group. Researcher will compare the clinical improvement in two groups.
Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani. It is characterized by skin lesions in which parasites can be identified, in a patient who is otherwise fully recovered from VL or exposed to L. donovani (LD) infection. It occurs in the Indian subcontinent (mainly India and Bangladesh) as well as in Africa (mainly Sudan). It is now established that PKDL patients play an important role in transmission of LD parasite where chronic PKDL patients have been implicated in major VL outbreaks in the past. Though VL cases are in decline due to extensive programmes conducted by NKEP, PKDL cases are in the rise and VL:PKDL ratio has risen from 1:0.47 to 1:1.21 from 2016 to 2020. In this current situation, elimination of PKDL cases is of crucial importance in the current VL elimination efforts in Bangladesh as well as in the Indian subcontinent. Knowledge gap: Currently there are no satisfactory treatments for any forms of PKDL. Both miltefosine and Ambisome® as monotherapy have shown to be effective. However, with the current recommended scheme there are some drawbacks such as the length of the treatment with miltefosine alone (8-12 weeks), toxicity related to it; a high dose Ambisome® (total dose of 20 mg/kg) given frequently in 4 divided dosage often causes adverse events (e.g. pancytopania, hypokalemia, increased creatinine level etc.). There is also the potential risk for development of resistance with miltefosine as monotherapy. Ivermectin has been proven to have a significant leishmanicidal effect by several experimental studies at higher doses without significant toxicity and may offer shorter duration of treatment thus preventing prolonged hospitalization. Another possible advantage is reduction of cost. These principles can be applied to PKDL, where the need for an ambulatory treatment with a highly safe, efficacious and user friendly regimen is even more pressing as the patients feel otherwise healthy, except for the rashes. Relevance: This study aims primarily to improve current treatment options. In addition, this will be the first human study ever in PKDL in relation to Ivermectin, in which outcome will be described in clinical, parasitological and immunological terms. Ultimately this study findings will help National Kala-Azar Elimination Program (NKAEP) to adopt specific strategies for elimination of PKDL cases. Hypothesis (if any): Oral ivermectin in multiple doses is safe and more effective than Miltefosine for the treatment of PKDL cases. Objectives: To measure the safety and efficacy of Ivermectin monotherapy regimen (60 mg oral on five consecutive days, for three consecutive months) in comparison to oral Miltefosine allometric dose for twelve weeks, for treating PKDL patients in Bangladesh. Methods: This will be a comparative, open label, non-blinded, individually randomized, proof-of-concept Clinical Trial to assess the safety and efficacy of oral Ivermectin monotherapy (5 x 12 mg daily at a total dose of 60 mg per month for three consecutive months, 180 mg in total) and Miltefosine monotherapy (50 mg twice daily for 12 weeks) in treating PKDL patients in Bangladesh. All participants will be recruited at SKKRC, Mymensingh with due consent. All patients will be followed up for 12 months. Cure assessment will be performed. Outcome measures/variables: Safety and efficacy of Ivermectin for PKDL treatment will be determined.
Title: Effect of Pyridoxine as Add-on Therapy with Standard Treatment in Obsessive Compulsive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial Purpose of the study: This study aims to examine the effect of Pyridoxine with standard treatment in Obsessive Compulsive Disorder patients. Method: It will be a prospective type of interventional study to to assess the effects of Pyridoxine along with standard treatment in OCD patients. The study will be conducted in the Department of Pharmacology,BSMMU and Department of Psychiatry, BSMMU, from September 2022 to July 2024. A total of 76 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A will consist of 38 patients who will receive tablet pyridoxine 25 mg twice daily with standard treatment and group B would consist of 38 patients who will receive placebo twice daily along with standard treatment for 8 weeks. To see the effects of pyridoxine, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before pyridoxine administration) and 8 weeks after intervention(after pyridoxine administration). Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), RBC glutathione (GSH) would be performed at baseline (before pyridoxine administration) and 8 weeks after intervention. Ethical consideration: The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting. The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.
This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.
Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens
Background (brief): 1. Burden: Diarrhea is the second deadliest disease for under-five children globally and the situation is more serious in developing countries. It was responsible for 688 million illnesses and 499,000 deaths worldwide in children less than 5 years of age in 2015 (Kotloff, 2017). Majority of the deaths from diarrhea occur before the second birthday of the children and it contributes to more than 20% of overall death in infants and young children. 2. Knowledge gap: Oral rehydration solution (ORS) is being used as a standard treatment for acute watery diarrhea for long time and which is one of the best inventions in the history of medicine. The ORS currently recommended by the WHO/UNICEF contains glucose, sodium chloride, potassium chloride, and tri-sodium citrate dehydrate, which is optimal for rehydration of patients of all ages with dehydration from acute diarrhea of any aetiology. However, oral rehydration therapy (ORT) with the present ORS formulation has certain limitations - it does not reduce the volume, frequency or the duration of diarrhea. Additionally, the failure of present standard ORS to reduce dramatically stool output likely contributes to the relatively limited use of ORS by mothers as they do not feel that ORS is helping their child from the episode of diarrhea. Thus, it warrants the development of newer and improved formulation of ORS to become more effective against diarrhea. 3. Relevance: It has been reported that the glucose contained in standard ORS may fail to absorb fluid and electrolytes adequately from gut and worsen diarrhea in different patho-physiological ways as the present WHO ORS is hypo-osmolar. Whereas, certain neutral amino acids (e.g. glycine, L-alanine, L-glutamine) are able to enhance the absorption of sodium ions and water from gut. By using this concept, the University of Florida (UF), developed a sugar-free, shelf-stable amino acid-based hydration medicinal food named 'VS002A' that effectively rehydrates, and improves barrier function of the bowel following infections targeting the gastrointestinal tract. So, the investigators ought to know whether VS002A will be superior or not to WHO-ORS in the treatment of acute non-cholera watery diarrhea in infants and young children. Hypothesis (if any): The amino acid-based ORS "VS002A" will reduce duration of non-cholera watery diarrhea in infants and young children when compared to treatment with standard WHO-ORS. Objectives: To compare the efficacy of amino acid-based ORS "VS002A" compared to standard Glucose-based WHO ORS in infants and young children suffering from acute non-cholera watery diarrhea. Methods: - It will be a randomized, double-blind, two cell clinical trial at Dhaka Hospital of icddr,b. Total 312 (156 in each arm) male children aged 6-36 months old with acute (onset <48 hours) non-bloody watery diarrhea will be included in this study. However, patients with severe malnutrition, any systemic illness, cholera, unwilling to comply with study protocol, remain significantly dehydrated 4 hours after intravenous fluid infusion (if required at start), has documentation of taking antibiotics or antidiarrheal 48 hours before admission will be excluded. - Intervention arm participants will get amino acid ORS (VS002A) and control arm will get standard glucose based WHO-ORS. Other aspects of clinical managements for diarrhea as per hospital guideline will be similar in both cases and controls