Clinical and Molecular Risk Factors of Anti-tubercular Therapy Induced Hepatitis.

Background: This is a case-control study aimed at evaluating clinical as well as molecular risk factors for occurrence of ATT induced hepatitis in Northern Indian population.

Methods: 100 patients of tuberculosis were recruited from both Outdoor patient department and wards of Lok Nayak Hospital, New Delhi. 40 out of 100 patients who developed ATT induced hepatitis were taken as test group and 60 out of 100 patients who didn't develop liver dysfunction on ATT were taken as controls and studied and compared for clinical factors such as age, gender, nutritional status, HBsAg carrier, chronic hepatitis C and HIV infection.

A phase III, randomized controlled study to assess the safety and immunogenicity of a semi-synthetic diphtheria, tetanus and whole-cell pertussis vaccine in Indian infants.

Background: Reactions to DTwP vaccine are well known and are a matter of great concern, much for the development of next generation combination vaccines. To avoid such reactions which occur from foreign compounds, WHO suggested manufacture of DTwP vaccine using semi-synthetic medium. The phase III trial reported here was conducted to assess the immunogenicity, tolerability and safety of a new DTwP vaccine manufactured using semi-synthetic medium for both tetanus and diphtheria toxoids in comparison with the routinely manufactured DTwP vaccine.

A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6-14 weeks.

Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial reported here was conducted to assess and compare the immunogenicity, tolerability and safety of two quadravalent vaccines, Quadrovax(®) (new vaccine), and TETRAct-Hib(®) (available in the market) in a multicentre study, in India. In all, 361 infants aged 6-8 weeks were enrolled, out of which 339 completed the study.

Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children.

Objective: An open label, controlled clinical study was conducted in Indian infants aged 6-14 weeks to compare the immunogenicity and safety of a reconstituted pentavalent vaccine (DTwP-HBV+Hib) of Serum Institute of India Ltd (SIIL) with TritanrixHB+Hiberix vaccine of Glaxo Smithkline (GSK).

Methods: Eligible infants were randomized to receive three doses of the study / comparator vaccine. The vaccines were reconstituted prior to administration, by mixing DTwP-HBV (liquid) with the Hib (lyophilized) vaccine.

Tumour necrosis factor-alpha and soluble Fas ligand as biomarkers in non-acetaminophen-induced acute liver failure.

Objectives: Cytokines as prognostic markers in acute liver failure (ALF) have not been evaluated in the Indian subcontinent with hepatitis E as the commonest aetiological agent. We investigated the clinical significance of proinflammatory/apoptotic cytokines soluble Fas ligand (sFasL) and tumour necrosis factor (TNF)-alpha in ALF of specific aetiology.

Methods: A total of 82 cases, 37 ALF and 45 acute hepatitis (AH), and 60 healthy controls were recruited.

Use of VSL[sharp]3 in the treatment of rotavirus diarrhea in children: preliminary results.

Unlabelled: We conducted a double-blind randomized placebo-controlled study to evaluate efficacy and tolerability of VSL[sharp]3 (CD Pharma India) in the treatment of acute rotavirus diarrhea in children. The patients were randomly assigned to receive 4 days of oral treatment with VSL[sharp]3 probiotic mixture or placebo in addition to usual care for diarrhea.

Results: Out of 230 rotavirus-positive acute diarrhea children, 224 children completed the study, (113 in the drug group and 111 in the placebo group).

The seroepidemiological study on cytomegalovirus in women of child-bearing age with special reference to pregnancy and maternal-fetal transmission.

We screened 500 women of childbearing age belonging to different socioeconomic class for the presence of IgM antibodies against cytomegalovirus (CMV) infection by ELISA. Among these were 70 pregnant women, positive for CMVspecific IgM antibodies, whose newborns were also tested for the same. IgM positivity was found to be 5.