Treatment of early neuropathy in leprosy (TENLEP) trials
Principal Investigator Dr. Vanaja P. Shetty
Participating centers National JALMAInstitute for Leprosy and Other Mycobacterial Diseases, Agra, India. Lalgadh hospital, Nepal. Nilphamari Leprosy Hospital, Bangladesh. Dr.Soetomo Hospital Surabaya , Indonesia
Collaborator with FMR Bombay Leprosy Project (Dr. VV Pai)
Project team Ms. Gospi Capadia, Dr. Kulbhushan Pawar, Dr. Ashish Khodke
Funders Netherlands Leprosy Relief; Turing Foundation; American Leprosy Missions; German Leprosy & TB Relief Association; Ordre de Malta
Duration January 2011 to December 2015
Budget Rs.96.67 Lakhs
International multi-centre randomized, double blind controlled trials in Leprosy patients from Brazil, Ethiopia, India, Indonesia and the Philippines
To determine whether steroid treatment of early sub-clinical NFI detected with sensory or motor NC & WDT would be of prognostic benefit to patients in terms of sensory or motor function (MF, VMT, NC, WDT and activities of daily living).
To determine whether steroid treatment of 6 months duration is more effective than treatment of 4 months duration in restoring nerve function in patients with clinical sensory and/motor NFI of recent onset (<6 months).
Primary and secondary outcome measures will include nerve function assessment, activities of daily living, reaction severity.