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Safety/toxicity evaluation of a new Ayurveda drug formulation Sudarshana Suspensio

Phase 1
Conditions
Fever (proposed indication)
Registration Number
SLCTR/2015/005
Lead Sponsor
HETC Project, Ministry of Higher Education
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow up complete
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

1.Age group of 18-60 years at the time of enrollment, of either sex with weight less than 60kg
2.Those who have no known systemic disorders, such as hypertension, diabetes mellitus, hypercholesterolemia and chronic arthritis
3. Those who have no history of drug allergy.
4.Those who have no history of intolerance to Sudarshana Powder or similar compounds
5. Women should be non pregnant and non breast feeding.
6. Only those who can write and read languages of English or Sinhala.

Exclusion Criteria

Concurrent treatment with any Ayurveda or Western medicine

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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