Trial design and patients
leptospirosis, dyspepsia, tubulitis, kidney diseases, backache, interstitial inflammation, obstructive kidney diseases, fibrosis, dysuria, infection, tubular atrophy, feverishness, arthralgia
RENAL, LEPTOSPIROSIS, KIDNEY DISEASES, FIBROSIS, ACUTE INTERSTITIAL NEPHRITIS, INFECTION, INTERSTITIAL INFLAMMATION, RENAL PARENCHYMAL DISEASE, RENAL DISEASES
This study is a single-centred prospective double-blinded randomized clinical trial. This was a factorial design where two treatments were combined for evaluation in a single study. The trial was conducted at the satellite renal clinics in the North Central Regions and the Dialysis and Transplant unit of Teaching Hospital Kandy, in Sri Lanka.AIN of unknown aetiology, an acute manifestation of CKDu which is diagnosed after exclusion of known causes for kidney diseases by history, laboratory tests and histology. Adults without any known premorbid kidney diseases from CKDu endemic regions, particularly presenting with recent onset backache, feverishness, dysuria, arthralgia and or dyspepsia were screened by serum creatinine and urinalysis. A clinical history was taken to exclude premorbid renal diseases, and recent exposure to nephrotoxins, such as over-the-counter medications non-steroidal anti-inflammatory drugs (NSAID) and proton pump inhibitors (PPI), and other treatments containing aristolochic acid. Aristolochic acid has been used in Ayurveda and traditional medicine in Sri Lanka as an ingredient of many herbal decoctions [Patients were diagnosed as probable AIN in the satellite renal clinics after ascertaining a few elevated serum creatinine measurements (> 116 males and > 98 µmol/L for females) and associated red cells, pus cells, and proteins in urine sediments, often within 2 weeks duration. Urine culture positives excluded. Renal ultrasonography (grayscale) was performed to confirm the presence of renal parenchymal disease, to exclude any obstructive kidney diseases, and to assess whether kidneys were not shrunken and of enough size (> 9 cm bipolar length) for biopsy. The normal sizes of kidneys for healthy individuals of CKDu endemic regions in Sri Lanka are 9.83 (1.49) cm for males and 9.46 (1.63) cm for females [Renal biopsies were examined with routine and special stains and direct immunofluorescence staining to detect immune complexes of IgG, A, and M, and complement. AIN was confirmed if there was interstitial inflammation and wide-spread tubulitis away from areas of interstitial and glomerular fibrosis, and tubular atrophy (Fig. Light microscopy images of acute interstitial nephritis (AIN) from CKDu endemic regions of Sri Lanka. Histology of MAT test with a fourfold or greater rise 2 weeks apart samples have been using to diagnose cases of leptospirosis in Sri Lanka. Besides, a single reading of > 1/400 titre is supportive in clinically suspected cases when the second sample is not feasible. A titre of 1/100 or 1/200 is considered a probable case or a past infection in leptospirosis endemic regions, according to Haake and Levett et al., 2014. Cases of leptospirosis are diagnosed based on the MAT test when other serological tests and PCR amplification are not available for routine practice in low socioeconomical setups in Sri Lanka.Biopsy-confirmed AIN cases of unknown aetiology were randomized and allocated for treatments. Serial creatinine and urinalysis were performed according to the study protocol.