Skip to content

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

A phase I study of the safety/ possible toxicity of a novel Ayurvedic preparation, Sudarshana Suspension.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2015/005
Enrollment
Unknown
Registered
2015-03-02
Start date
2015-03-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever (proposed indication)

Interventions

Healthy adult volunteers will be recruited by an open advertisement displayed in the notice boards of the University of Sri Jayewardenepura and Institute of Indigenous Medicine, University of Colombo.

Sponsors

HETC Project, Ministry of Higher Education
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Concurrent treatment with any Ayurveda or Western medicine

Design outcomes

Primary

MeasureTime frame
Changes in the following bio-markers 1. Alanine aminotransferase (ALT) 2. Aspartate aminotransferase (AST) 3. Gamma-glutamyl transferase (Gamma-GT) 4. Alkaline phosphatase 5. Haemoglobin (Hb) 6. Urea in serum 7. Serum Creatinine Volunteers will be requested to maintain the diary recording noting the time of drug administration, any unusual symptoms (vomiting, headache, diarrhoea) and time of onset and duration of the symptoms during the treatment period and follow up period. [In each subject, basic epidemiological and anthropometric data (age, sex, weight) including visit check list will be recorded by the principal investigator and also the volunteer diary will be recorded by the volunteer ]

Secondary

MeasureTime frame
After successive intervention of phase I , phase II studies will be planned according to ERC approval. [At baseline, day 3 and day 8]

Countries

Sri Lanka

Contacts

Public ContactDr. W.A.S.S.Weerakoon

Lecturer and Consultant Ayurvedic Paediatrician

sarojaweerakoon@yahoo.comTel: 0112694308

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026