CTRI/2012/05/002709.

HighlightsPentavalent reassortant rotavirus vaccine (BRV-PV) was tested for lot-to-lot consistency in Indian infants.The vaccine demonstrated safety profile similar to licensed Rotarix®.Lot-to-lot consistency in the immunogenicity of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies.The immune responses between the pooled BRV-PV arms and Rotarix® were comparable.

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Background & objectives:Basti (medicated enema) is a popular Ayurvedic intervention recommended for obesity. However, there are no data to show whether any physiological or biochemical changes occur following this treatment. This study was conducted to identify the immunological and metabolic changes in obese individuals after a therapeutic course of Basti.Methods:Thirty two obese individuals (18 and 60 yr) with a body mass index (BMI) ≥30 kg/m2 who received a therapeutic course of 16 enemas (Basti) followed by a specific diet and lifestyle regimen for a period of 32 days as their treatment for obesity, were enrolled in the study. Clinical examination, measurement of immune and metabolic markers were done before (S1), immediately after (S2) and 90 days after the completion of therapy (S3).Results:A significant reduction (P<0.001) in weight, BMI, upper arm and abdominal circumference was seen at S3, along with a decrease in serum interferon (IFN)-γ (P<0.02), interleukin (IL)-6 (P<0.02) and ferritin (P<0.05) and increase in IgM levels (P<0.02). Peripheral blood lymphocytes (PBLs) stimulated with anti-CD3 monoclonal antibodies showed significant increase in reactive oxygen species (ROS) generation and calcium flux after Basti. All organ function tests revealed no changes.Interpretation & conclusions:Our study documents that a therapeutic course of Basti modulates immune responses by regulating pro-inflammatory cytokines, immunoglobulins and functional properties of T-cells. These changes are associated with a reduction in the body weight which is maintained even after three months of treatment. The study also documents the safety of Basti procedure.