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NCT ID: NCT03754712 Recruiting - MDD Clinical Trials

Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder

Start date: March 10, 2018
Phase: N/A
Study type: Interventional

Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD.

NCT ID: NCT03754647 Recruiting - OCD Clinical Trials

Effect of Vitamin C Upon SSRI-treated OCD Patients

Start date: December 14, 2017
Phase: N/A
Study type: Interventional

Title: Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder (OCD) patients. Purpose of the study: This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients. Method: It will be a prospective type of interventional study to to assess the effects of vitamin C along with SSRIs upon OCD patients. The study will be conducted in the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A total of 90 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 45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the effects of Vitamin C, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma vitamin C level would also be performed at baseline (before vitamin C 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.

NCT ID: NCT03753646 Recruiting - Clinical trials for Early Childhood Development

Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behavior in Rangpur City Corporation, Bangladesh

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Burden: Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. The health care platform is not well designed in primary health care delivery for urban health system but presently almost 30 percent people are living in urban area of the country. Knowledge gap: Little is known about what happen if psycho social stimulation is provided using urban lactating allowance program on children's cognition and behavior. There is little information about nature and bottleneck of Early Childhood Development (ECD) activities available in the urban Bangladesh. Relevance: This is an opportunity to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program on disadvantaged children's development. As the urban health system is complex, patchy and fragmented, prior to this intervention An analysis will be done on ECD services and its bottleneck in urban area through Tanahashi framework. Hypothesis (if any): Adding psycho social stimulation to urban lactating allowance program will have additional effect on children's cognitive, motor and language development and behavior compared to the comparison group Secondary Hypothesis: Additionally the intervention will- improve mothers' quality of life and reduce their depressive symptoms be cost effective, Objectives: - To evaluate the effect of integrated urban lactating allowance and psycho social stimulation on children's cognitive, motor and language development and behavior - To measure nature and bottleneck of ECD services in urban Bangladesh Secondary objectives: To measure effect of the programs on: - mothers' quality of life and mental health (depression symptoms) - cost effectiveness of the intervention Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho social stimulation; (ii) Only lactating allowance Outcome measures/variables: Children's cognitive, motor and language development measured on Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive symptoms , household food security status, socioeconomic status, quality of home stimulation using family care indicators, Mother's knowledge on child care and development, children's growth measured by length/height, weight and head circumference,mothers' height, weight and mid upper arm circumference, direct and indirect cost of the project.

NCT ID: NCT03750747 Recruiting - Hypoxemia Clinical Trials

Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). The investigators will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities (phase 2). This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH&FWC) will be randomly assigned to comparison and intervention facilities.

NCT ID: NCT03738956 Recruiting - Clinical trials for Axial Spondyloarthritis

Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial

Start date: September 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Title Efficacy and Safety of Tofacitinib in the Treatment of NSAID-Refractory Axial Spondyloarthritis: A Clinical Trial Background: Axial spondyloarthritis (axSpA) is a chronic systemic inflammatory rheumatic disease affecting mainly sacroiliac joints and spine. There are limited options for treatment. Initial treatments are patient's education, regular physical exercise and nonsteroidal antiinflammatory drugs(NSAID). If the patients do not respond to at least two NSAIDs in full dosages for at least one month then it is called NSAID refractory axSpA. In these cases biologics like-tumor necrosis factor α blockers are the options for treatment. Tofacitinib is a new drug has been proven to be effective for treatment of rheumatoid arthritis , psoriasis , inflammatory bowel disease and supposed to be effective in spondyloarthritis. This study is aimed to assess the efficacy and safety of tofacitinib in NSAID refractory ax SpA with a view to find a safe, effective and affordable treatment modality. Method: This open label uncontrolled clinical trial with tofacitinib will be conducted in NSAID refractory axSpA (age >18 years) patients. Study participants will be enrolled after having informed written consent from the outpatient department of Rheumatology, Bangabandhu sheikh mujib medical university. Assessment of Spondyloarthritis International Society (ASAS) criteria will be followed for diagnosis of ax SpA. Patients failing a trial of 2 different NSAID each for at least 2 weeks with optimum dosage without response or with partial response and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (range, 0-10) or Ankylosing spondylitis disease activity score-C reactive protein(ASDAS-CRP)>2.1 will be considered as primary entry criteria for this study. Baseline evaluation will include Bath AS Disease Activity Index (BASDAI), Functional Index (BASFI) , Ankylosing spondylitis disease activity score-C reactive protein(ASDASCRP) and Ankylosing spondylitis disease activity score-erythrocyte sedimentation rate(ASDAS-ESR). Laboratory tests like CBC, ESR, CRP, SGPT, Serum creatinine and X-ray pelvis A/P view or X-ray both SI joints modified Ferguson veiw (to see both SI and hip joints ), HLA-B27(if needed), CXR P/A view and MT test or Interferon Gamma Release Assay(IGRA) will be done. After considering inclusion and exclusion criteria eligible patients will be included for this study. All patients will be put on 5mg tofacitinib BD. NSAID and adjuvant analgesics will be used if needed. Follow up will be done at 4th, 12th and 24th week. Response to treatment will be evaluated by assessement of spondyloarthritis society (ASAS) response criteria. More than 20% improvements from baseline will consider as primary response at the end of 12th week. Those patients who will not achieve ASAS20 response at 12th week, will be given 10 mg tofacitinib BD. Efficacy will be assessed at the end of 24th week by ASAS20, ASAS50, ASAS70, ASDAS-ESR, ASDAS-CRP, BASDAI, Bath ankylosing spondylitis functional index(BASFI). Adverse effects will be assesed by history, Physical examinations and investigations. The entire study subjects will be informed about the nature, purpose and implication of the study as well as whole spectrum of benefits and risk of the study. Ethical clearance will be taken from the IRB of BSMMU.

NCT ID: NCT03641079 Recruiting - Clinical trials for Keratotic Nodular Size

Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease

Start date: September 16, 2017
Phase: Phase 2
Study type: Interventional

Arsenicosis is a major health problem in Bangladesh. Long term exposure of arsenic causes keratosis of palm which reduce working capacity of patient. It also causes invasive skin lesions like Bowen's disease which has a risk to develop squamous cell carcinoma. Brinjal peel is well known for its antioxidant and anticancer properties. So this study will be conducted to identify the compound from brinjal peel extract and to see its outcome on keratosis and Bowen's disease.

NCT ID: NCT03641001 Recruiting - Feeding Behavior Clinical Trials

Nutrition Intervention Integrated With Food Voucher to Improve Child Growth and Feeding Practices

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Brief Summary: Background: The period from birth to two years of age is the "critical window" for the promotion of optimal growth, health, and development. Insufficient quantities and inadequate quality of complementary foods, poor child-feeding practices and high rates of infections have a detrimental impact on growth. Approximately one-third of children less than 5 years of age in developing countries are stunted, and large proportions are also deficient in one or more micronutrients. An estimated 6% or 6 hundred thousand under-5 deaths can be prevented by ensuring optimal complementary feeding (CF) only. Knowledge gap: Even though the importance of CF is established, children < 2y are being fed complementary foods with poor nutrient quality, particularly in resource poor countries like Bangladesh. Relevance: Approximately 36% under 5 children are stunted in Bangladesh. Only 23% of children age 6-23 months is fed appropriately based on recommended infant and young child feeding (IYCF) practices. The routine diet of the population including children is mainly plant based and lacks adequate protein and other essential nutrients. Hygiene is also an issue as only 21% of rural households use soap and water during handwashing. An intervention package including CF counselling, WASH and micronutrient powder (MNP) could be potential option for optimizing complementary feeding practice in rural Bangladesh. Hypothesis: An integrated intervention package will improve child growth in terms of length and complementary feeding practice in the selected intervention area from rural Bangladesh compared to control area. Objectives: 1. To improve nutritional status (length for age Z-score or LAZ) of the children (6-12 mo) through food voucher to promote improved recipe and intervention package with 12 months of intervention period. 2. To improve young child feeding practices following counselling Methods: This will be a community based cluster randomized trial. Group I (intervention) will receive a package of intervention (child feeding counselling, WASH and micronutrient powder) along with food voucher to support feeding their children a homemade snack following a newly developed recipe (suzi firni for <1 year, suzi halua for >1 yr) and Group II (Control) will receive usual health meassages. Baseline and endline survey will be conducted. Growth Monitoring Promotion (GMP) will be done monthly to monitor the growth of the children and utilization of food voucher. Data on child feeding, morbidity and anthropometry (length and weight) will be collected monthly. Outcome measures/variables: 1. Difference in mean LAZ of the children between intervention and control group 2. Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group 3. Difference in proportions of mothers in terms of correct knowledge and practice on CF

NCT ID: NCT03635853 Recruiting - Clinical trials for Improvement of Keratotic Nodular Size

Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis

Start date: September 16, 2017
Phase: Phase 2
Study type: Interventional

Arsenicosis is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to arsenicosis which is characterized by dermatological features i.e. diffuse melanosis , spotted melanosis and keratosis. Cock's comb is rich in hyaluronic acid, chondroitin sulfate A, B, C and heparin. Hyaluronic acid is a hydrophilic molecules and is a constituent of wound extracellular matrix and facilitate wound healing.This work is aimed to identify the component that is effective in palmar arsenical keratosis.

NCT ID: NCT03632733 Recruiting - Clinical trials for Keratotic Nodular Size

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Start date: January 21, 2018
Phase: Phase 2
Study type: Interventional

It had been found in certain studies that there is an alteration of normal skin flora in patients with arsenical keratosis. The relationship between such altered skin flora and development of keratosis in arsenicosis is not established or explored.There is no such study where effects of antimicrobials have been evaluated as the treatment of arsenical keratosis. So the present study is designed to see the effects of antimicrobials on the altered skin flora (Enterobacter and Aspergillus) in patients with palmar arsenical keratosis.

NCT ID: NCT03600025 Recruiting - Clinical trials for Typhoid Fever Patients and Healthy Volunteers to Receive Typbar-TCV Vaccine

Cellular Immune Responses in Typhoid Fever Patients and Vaccinees

Start date: July 15, 2018
Phase: Phase 1
Study type: Interventional

Typhoid fever caused by Salmonella Typhi and Paratyphi causes over 21 million cases of febrile illness and 200,000 deaths are attributed to enteric fever each year. Typhoid fever is an enteric infection that results in febrile illness. Typhoid fever causes significant morbidity in the developing world especially young children.S. Typhi specific antibody responses are elicited in typhoid fever and following typhoid vaccination. Cross-reactive multifunctional CD+4 T cell mediated IL-17 responses have been shown in typhoid fever. As S. Typhi as an intracellular pathogen, cellular immune responses might be central to protection. S. Typhi peptide subunit vaccine elicits CD+4 T cell responses that correlate with protection in mice. The role of mucosal associated invariant T cell (MAIT) and natural killer (NK) cell responses in typhoid fever or following vaccination remain poorly understood. Transcriptome profiling of human immune responses to S. Typhi infection is not clearly understood. Establishing successful infection by S. Typhi evasion of T cell and neutrophil responses need to be investigated to better understand the correlates of protection.