Therapeutic evaluation of a Ayurveda drug preparation Sudarshana suspension in febrile childre
- Conditions
- Fever
- Registration Number
- SLCTR/2015/026
- Lead Sponsor
- HETC Project, Ministry of Higher Education
- Brief Summary
Following treatment with the novel preparation Sudarshana suspension, fever completely resolved within 72 hours. However, when palatability of the two preparations was concerned it was found that the palatability of the Sudarshana suspension was much better and the compliance was higher (Figures 4.15). The overall efficacy of the new drug; Sudarshana suspension (SS) was significant (p< 0.005) in comparison to the standardized Ayurveda drug, Sudarshana powder (SP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Children of either sex aged 6- 12 years at the time of enrollment
2. Axillary temperature of 37. 5°C or above at arrival and/or after one hours observation
3. No other antipyretic medication given
4. Admitted by parents or legal guardians who can write and read English or Sinhala
5. Only patients with fever with no other signs and symptoms of systemic illness
1. Weight below the third centile for age
2. Those receiving anticoagulant treatment
3. History of intolerance to Sudarshana powder or similar compounds
4. Previous occurrence or current symptoms of peptic ulceration or gastrointestinal bleeding
5. Diagnosis of severe liver, heart, kidney, or systemic disease including malignancy
6. On other medication which needs to be taken during the study or in the six hours prior to recruitment
7. Those receiving any other antipyretic or anti inflammatory drugs.
8. Any history of drug allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Therapeutic effect of the medications within the first 6 hours using a five point scale: 0= no effect (fever does not resolve) 1= fever resolves completely within 6 hours 2= fever resolves completely within 5 hours 3= fever resolves completely within 3 hours 4= fever resolves completely within 2 hours 5= very good effect (fever resolves completely within 1 hour)<br><br><br><br><br>2.Overall therapeutic effect of the medication will be recorded on a four point scale: 0= no effect (No change in the body temperature) 1= fever resolves completely within 72 hours 2= fever resolves completely within 48 hours 3= fever resolves completely within 24 hours 4= very good effect (fever resolves completely within 6 hours )<br><br> [1. Within the first 6 hours following administration<br><br>2. At the end of three days or at complete resolution of the fever.<br>]<br>
- Secondary Outcome Measures
Name Time Method Palatability of medications using a five point scale [Immediately following the first dose and at the end of 6 hours]<br>