There are about 5618 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.
A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI)
Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock. Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC. Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock.
This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes. Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
It is known that Immunosuppression post-Liver transplant is central to achieving optimal outcomes in liver transplant recipients. It is required to maintain an adequate balance between reducing rejection and toxicities. Mainstay drugs for maintenance therapy are Calcinuerin inhibitors - Tacrolimus versus cyclosporine. Tacrolimus is preferred, as it has less rejection and better graft survival. However, there is risk of renal and metabolic toxicities. Tacrolimus is bound mainly to alpha1-acid-glycoprotein (encoded by the ABCB1gene) expressed on various epithelial and endothelial cells and lymphocytes. Elimination occurs by metabolizing enzymes of cytochrome P450 system, with biliary excretion (95%) of metabolites (majority) with minority through urine (2.4%). Demethylation and hydroxylation of tacrolimus occurs by hepatic and intestinal CYP3A isoforms (CYP3A4 and CYP3A5). Among the factors that play an important role in the pharmacokinetics of tacrolimus, thus affecting the tacrolimus trough levels in the body and in turn influencing the dosing of the drug required to maintain an adequate balance between reducing rejection and toxicities, genetics plays an important role. Increased expression of CYP3A5 causes more metabolism of tacrolimus and hence affecting the tacrolimus concentration/weight-adjusted dose (C/W-D) ratio in the body. The wild type (CYP3A5*3) are slow metabolizers and mutant ones (CYP3A5 *1/*1 and CYP3A5 *1/*3) are fast metabolizers. Fast metabolizers have a low C/W-D ratio and require higher Tacrolimus dosing and are thus susceptible to renal and metabolic toxicities, EBV viremia and post transplant lymphoproliferative disorder. Polymorphisms in ABCB1 (c.3435C>T) are also known to influence tacrolimus dosage in the first week of transplant (C/D ratio was lower in ABCB1 3435CC in comparison to CT and TT). There is no such data in pediatric liver transplant setting from Indian subcontinent. The aim of the study is to study the prevalence of CYP3A5 polymorphisms in the donors and ABCB1 polymorphisms in the recipients undergoing Paediatric liver transplant and their influence on Tacrolimus levels and graft function.
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated.
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.[1] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.[2,8] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation.
The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.