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Therapeutic evaluation of a Ayurveda drug preparation Sudarshana suspension in febrile childre

Phase 2
Completed
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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