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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 00:59:48 GMT) CTRI Number CTRI/2019/08/020521 [Registered on: 02/08/2019] - Trial Registered Prospectively Last Modified On 01/07/2021 Post Graduate Thesis Type of Trial Observational Type of Study Case Control Study Study Design Other Public Title of Study Study of malaria pathogen and drug response Scientific Title of Host mediated regulation of Invasion, Egress and Drug response of Plasmodium falciparum and Study Plasmodium vivax Malaria Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Miss Sowmya R Prabhu Trial Coordinator (multi-center study) Designation PhD student Affiliation Manipal School of Life Sciences, MAHE, Manipal Address Department of Biotechnology, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 India Phone 8652393738 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Saadi Abdul Vahab Query) Designation Professor Affiliation Manipal School of Life Sciences, MAHE, Manipal Address Department of Biotechnology, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 India Phone 9448984726 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr TGVasudevan Designation Associate Professor Affiliation Manipal School of Life Sciences, MAHE, Manipal Address Department of Biotechnology, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in India Phone 9741735917 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Manipal Academy of Higher Education, Manipal-576104, Karnataka. Intramural fund for research. Primary Sponsor Primary Sponsor Details Name Manipal Academy of Higher Education Address Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Sowmya Prabhu School of Life Sciences 3rd Floor, Department 8652393738 of Biotechnology, Manipal Academy of sowmya.prabhu@learn Higher Education, er.manipal.edu Manipal Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? KMC and KH Approved 09/04/2019 No Institutional Ethics Committee KMC and KH Approved 27/06/2021 No Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Sequelae of other specified infectious and parasitic diseases Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 5.00 Year(s) Age To 70.00 Year(s) Gender Both Details Case: Participants aged between 5-70 years infected with Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) malaria are included in this study.<br/> Control: Participants aged between 5-70 years who never had any Plasmodium infection and hailing from the same endemic area are included as control participants. <br/> Exclusion Criteria Exclusion Criteria page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Details Case: Participants under the age of 5 and above 70 are excluded from the study. Other exclusion criteria include pregnant women, participants undergone treatment for malaria for past 3 months Control: Pregnant women and participants with other clinical conditions are excluded from the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Identification of genetic variations First, second and third year Secondary Outcome Outcome Timepoints Identification of markers of malaria Third year resistance/susceptibility Target Sample Size Total Sample Size=1050 Sample Size from India=1050 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 06/08/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Not yet Brief Summary Malaria is a mosquito-borne infectious disease, caused by a Plasmodium parasite. The life cycle of Plasmodium within their human host is well known, yet control strategies are still insufficient to stop their spread. Understanding the interactions between the pathogens and the host may help development of strategies to target and control the Plasmodium development in humans. Host genetics plays a pivotal role in the outcome of the malaria disease. Small non-coding RNAs like miRNAs regulate the gene expression post-transcriptionally. They have been indicated to play a role in malarial pathogenesis. Some miRNAs are found to enrich only in parasitized RBCs compared with the normal uninfected RBCs, inhibiting parasite survival by forming human miRNA and parasite mRNA chimerics. The discovery prompted search for more such miRNAs that may have effect on the candidate genes of the host-parasite interactions. The clinical manifestations of malaria appear with the infection of host erythrocytes by Pv or Pf. Signaling via the heterotrimeric guanine nucleotide-binding protein (G?s) and the erythrocyte ?2-adrenergic receptor (?2AR) have been shown to regulate the parasite entry into RBCs. Identifying the possible target sites of miRNAs in the parasitic genes as well as those miRNAs that might target the host factors like ADRB2, and screening other genes for erythrocyte specific and liver specific proteins (LRP) associated with Plasmodium invasion would be of great interest. page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Resistance and relapse to anti-malarial agents has increased, threatening global efforts for the eradication of malaria. There is a need to develop novel therapeutic strategies to combat the same, including repurposing of existing drugs. In vitro studies to test the effect of the beta agonists, miR mimics and their comparison with anti-malarials is worthwhile. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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