There are about 3676 clinical studies being (or have been) conducted in India. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The treatment options majorly consist of medical management with at least 6-month long treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects have disease relapse that requires prolonged therapy. It is likely that a longer duration of itraconazole would have a higher response rate and thus, lower risk of relapse after discontinuation of therapy. In this randomized controlled trial, we compare the clinical outcomes of six months versus twelve months of itraconazole therapy in treatment naïve subjects with chronic pulmonary aspergillosis
To the best of our knowledge, only two studies are available which have provided a direct comparison between outcome of nonsurgical retreatment and endodontic surgery. The results of the two studies are contradictory in nature. Two systematic reviews conducted to explore the issue also could not draw any definitive conclusions and suggested that further research is necessary to find out effects of surgical versus nonsurgical approach. Considering the very limited amount of data on this pertinent topic, there is apparent need of high quality randomized controlled studies to further investigate the difference in outcome between nonsurgical retreatment and endodontic surgery.
The pandemic of diabetes is increasing at an alarming rate. The prevalence of diabetes has risen in India by 123% over the last decade. In 1990, diabetes was not considered an important contributor to mortality in India but in 2013, it is ranked as the eighth most common cause of deaths in adult Indian population. There is now a growing understanding that diabetes runs in families and has a significant genetic basis. In this regard, it is noteworthy that from an ethnographic standpoint, Sindhi population in India has been both genetically and environmentally at an increased risk of stress, hypertension and cardiovascular diseases. Considering the nexus of metabolic diseases that include hypertension, obesity, dyslipidemia and diabetes it is therefore expected that this population may be at an increased risk of these metabolic conditions. However, exact prevalence of contributors to type 2 diabetes in the Sindhi population is unknown. The proposed study will estimate prevalence of type 2 diabetes in Sindhi families of Nagpur. Both the PIs have extensive experience with family studies which includes construction of pedigrees, using variance components methods, dissecting out genetic and environmental components of diseases and association of critical phenotypic traits with disease. The proposed study will tap this resource with a focus on the Sindhi families of Nagpur which are concentrated in the Jaripatka and Khamla areas. This study will exploit the current infrastructure in the Lata Medical Research Foundation to access these families and conduct a first-of-its-kind study in India. It is expected that this study will pave way for more extensive genetic, epigenetic and environmental studies of this population. It will also foster future collaborations with national and international health agencies. In that vein, the DISFIN pilot study represents the first step towards identification, quantification, prevention and control of type 2 diabetes in central India.
The aim of this study is to comparatively evaluate changes in periodontal healing, surgical time required and postoperative morbidity observed in patients undergoing osseous resection in crown lengthening procedure with conventional rotary instruments versus piezoelectric device.
The main aim of this prospective, randomized controlled clinical study is to: • To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.
Cirrhosis of liver is a leading cause of morbidity and mortality worldwide. Complications like ascites, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and hepatocellular carcinoma (HCC) portend a poor prognosis and further decreases survival in these patients. The major causes of cirrhosis include excessive alcohol consumption, viral hepatitis and non- alcoholic fatty liver disease. Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. Moreover, it requires lifelong immunosuppression and has considerable long term side effects including chronic renal failure, post-transplant lymphoproliferative disease and cardiovascular complications. The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that stem cells can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells, thereby contributing to hepatic regeneration. Thus, apart from hepatocytes and intrahepatic stem cells, bone marrow derived stem cells also participate in the liver regeneration process. Currently, there are two methods to mobilize stem cells from the bone marrow to the liver. One is administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow and their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients. Improved liver histology and survival has been noted in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF). Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and ACLF. However, there is a paucity of data on whether G-CSF improves survival and prognosis in patients with decompensated cirrhosis. Verma, Singh et al have shown in an open label trial that there was significantly better 12 month transplant free survival in ( GCSF+ Growth hormone + standard medical therapy group ) and ( G CSF + standard medical therapy group ) as compared to standard medical therapy group alone. CD 34+ cells at day 6 of therapy increased as compared to baseline. There was also a significant decrease of clinical scores, improvement in nutrition, better control of ascites, reduction in liver stiffness, lesser episodes of infection as well as improvement in QOL scores in the treatment groups having G CSF as compared to baseline. In a recent study by Newsome et al, a multicentre, open label randomized phase 2 trial, patients were randomized to standard care, treatment with subcutaneous G CSF or treatment with G CSF for 5 days followed by leukaphersis and IV infusion of CD 133 positive haematopoietic stem cells. They did not find any difference in MELD score over time in all 3 treatment groups. Serious adverse effects were more common in the G CSF groups than in standard treatment group. In a study by Kedarisetty CK et al. a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF & Darbopoietin α survived for 12 months more than patients given only placebo ( 68% vs. 26.9%; P = 0.001 ). The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo. In view of the conflicting results of the above studies and no studies on the use of multiple courses of GCSF in patients with decompensated cirrhosis in a double blind manner, the present study was undertaken to assess the safety and efficacy of G-CSF in patients with decompensated cirrhosis in the form of a double blinded RCT.
Lung cancer screening with low-dose computed tomography (LDCT) has been recently shown to result in a significant reduction in lung cancer-specific mortality. However, the utility of LDCT screening in developing countries with high incidence of tuberculosis has not been adequately studied. The investigators hypothesize that LDCT screening in tuberculosis endemic regions is likely to yield a large proportion of false-positive results, especially in the initial round of screening, posing a significant burden on the healthcare system. Herein, the investigators assess the utility of LDCT and its cost-effectiveness in India.
An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover oral drug-drug interaction study of spironolactone (perpetrator) and Digoxin (substrate drug) in healthy adult human subjects under fasting condition.
The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not.
In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.