Determining the Optimum Dose, Efficacy and Safety of an Ayurvedic Formulation, Link Natural Sudarshana (LNS) in Patients with Dengue, Randomised, Double-blinded, Placebo Controlled Phase II Clinical Trial

Phase 2

Conditions: Dengue

Registration Number: SLCTR/2024/015

Lead Sponsor: ?????

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of dengue patients who progress into critical phase.<br>Evidence of plasma leakage will be considered as: detection of free fluid in the abdomen or by the presence of a pleural effusion by an ultrasound (US) scan or by the presence of a rise in haematocrit of >20% of the baseline. [FBC will be done twice daily, Clinical assessments will be carried out at least 3 times a day until discharge]<br>

Secondary Outcome Measures