A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia

Lambert, SORCID logo (2015). A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction in Ethiopia. [Dataset]. London School of Hygiene & Tropical Medicine, London, United Kingdom. 10.17037/DATA.18.
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Data produced as part of a randomized controlled trial to investigate the efficacy and adverse effect profile of ciclosporin in comparison to prednisolone in patients with acute first time occurrence of T1R. Patients were randomized to one of two study arms (ciclosporin treatment or prednisolone treatment) and followed over a 32 week period to assess them for changes in clinical signs and adverse events.

Keywords

Leprosy, Leprosy reaction, Type 1 reaction, Adverse events, Ciclosporin, Prednisolone

Item Type Dataset
Description of data capture Data from each assessment was recorded on standardised Patient Record Forms (PRF) and kept in a set of case notes separate from other hospital record. Data was verified and entered into Case Record Forms (CRF) by the study physicians. Double data entry into a Microsoft Access 2007 database was performed by Saba Lambera and a data manager at ALERT/AHRI. The double entry was then verified using Epi-Info 3.5.4, with an initial rate of detected errors being under 10%. Errors in the data were verified and corrected in Ethiopia. Errors were traced back to the CRFs and correct. Epi-info was re-run and procedures repeated until two identical and correct databases were obtained. The MS Access data tables were subsequently transferred to SPSS v20 for analysis.
Capture method Measurements and tests
Collection Period
From
To
12 August 2011
24 July 2013
Date 1 October 2015
Geographical area covered (offline during plugin upgrade)
North Latitude
East Longitude
South Latitude
West Longitude
9.02783
38.847
8.91897
38.6963
Language(s) of written materials English
Creator(s) Lambert, SORCID logo
Associated roles Nicholls, P (Data Manager), Yamuah, L (Data Manager), Lockwood, D (Project Leader), Tsegaye, D (Data Collector) and Nigusse, S (Data Collector)
LSHTM Faculty/Department Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Participating Institutions London School of Hygiene & Tropical Medicine, London, United Kingdom
Funders
Project
Funder
Grant Number
Funder URI
Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other Studies
Hospital and Homes of St Giles
ITCRBY24
UNSPECIFIED
Date Deposited 11 Nov 2015 14:05
Last Modified 08 Mar 2024 16:50
Publisher London School of Hygiene & Tropical Medicine

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