Clinical trial of an Ayurvedic formulation in dengue fever
- Conditions
- Health Condition 1: null- Patients with confirmed dengue fever, Positive NS1
- Registration Number
- CTRI/2017/11/010586
- Lead Sponsor
- Central Council for Research in Ayurveda Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)Fever of >38Deg C of <72 hr duration and at least two of the following criteria indicating probable dengue infection:
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
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 <30), CHF, HIV ( CD4 <200) TB in intensive phase of treatment, malignancy, patients on radiotherapy, transplant patients, Nephrotic syndrome,
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study effect on capillary leak in Dengue fever as measured by serial ultrasound chest & abdomen for third space fluid accumulation <br/ ><br>2.Change in hematocrit <br/ ><br>3.Change in albumin level <br/ ><br>4.Virological Log Reduction (Virological Endpoint) <br/ ><br>5.Fever Reduction (Clinical Endpoint) <br/ ><br>6.Quantitative NS1 clearance <br/ ><br>7.Hematology Normalisation ) <br/ ><br>Timepoint: 1 2 3 4 5 7 14th day
- Secondary Outcome Measures
Name Time Method Safety: Proportion of patients experiencing adverse events and serious adverse eventsTimepoint: 14 Days