Health Condition 1: null- Patients with confirmed dengue fever, Positive NS1
Conditions
Interventions
Intervention1: AYUSH PJ-7: 700mg of trial formulation along with standard care
2 Tablets of 350mg BID for 10days
Control Intervention1: Placebo: 700mg of placebo along with standard care (2 Tablets o
Sponsors
Central Council for Research in Ayurveda Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1)Fever of >38Deg C of a. Lived or worked in or recent travel to dengue endemic area b. Nausea and vomiting c. Presence of rash d. Aches and pains, including headache, or retro â??orbital, muscle or joint pain 2) Positive NS1 by ELISA or IgM Dengue
Exclusion criteria
Exclusion criteria: 1.History of presently active intestinal disorders- Bleeding, mal-absorption, history of inflammatory bowel disease 2.Current usage of drugs â?? anticoagulants, diuretics, steroids, immunosuppressants 3.Any clinically significant acute illness 4.Known chronic diseases :- CKD ( GFR 5.History of severe drug and /or food allergies 6.Exposure to investigational agent within 30 day prior to study drug administration 7.Clinically significant abnormal physical exam unrelated to dengue fever 8.Pregnancy & lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To study effect on capillary leak in Dengue fever as measured by serial ultrasound chest & abdomen for third space fluid accumulation 2.Change in hematocrit 3.Change in albumin level 4.Virological Log Reduction (Virological Endpoint) 5.Fever Reduction (Clinical Endpoint) 6.Quantitative NS1 clearance 7.Hematology Normalisation ) Timepoint: 1 2 3 4 5 7 14th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Proportion of patients experiencing adverse events and serious adverse eventsTimepoint: 14 Days | — |
Countries
India
Contacts
Public ContactDr BS Prasad
KLE Universityâ??s
Outcome results
None listed