A Randomised, Double-blinded, Placebo controlled Phase II Clinical Trial to Determine the Optimum Dose, Efficacy and Safety of an Ayurvedic Formulation, LNS in Patients with Dengue

?????0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

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•Laboratory evidence of Dengue: All Patients with confirmed dengue infection by a positive dengue NS1 antigen detection test and confirmed by PCR test. The dengue NS1 antigen will be done by rapid immunochromatographic assays (rapid strip tests at the OPD). Those who provides informed written consent and who fulfil all of the following criteria will be recruited.
•Age: between 18-70
•* Both male and female
•Duration of illness: Equal or less than 48 hours of the onset of fever

•Those who already have evidence of fluid leakage.
•Fever for more than 48 hours
•Pregnant women
•Those who have known allergies to ingredients of LNS.
•Those who are unable to take the drugs orally.
•Those who have known hepatic impairment defined as following: All of the 3 following criteria
•should be present.
•Presence of any previously known liver disease
•A prolonged prothrombin time of 4-6 seconds or more
•An INR of >1.5
•Those with known renal impairment. They will be defined as those who fulfil either of the
•following criteria regardless of age, hypertension and diabetes. Patients will be inquired
•regarding presence of diabetes and hypertension and any pre-existing renal disease
•. They would have renal impairment if they have any of the following.
•- Predicted GFR <60 ml/min per 1.73 m2
•- Hereditary kidney disease
•- Recurrent or extensive nephrolithiasis (renal calculi)

发起方

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