Home » Trials » SLCTR/2015/005

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


SLCTR Registration Number


Date of Registration

02 Mar 2015

The date of last modification

Mar 03, 2019

Trial Status

Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied

Fever (proposed indication)

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura : No 775 /13 Ethics Review Committee, Institute of Indigenous Medicine, University of Colombo : No ERC 12/11

Trial Details

What is the research question being addressed?

What is the effect of the novel preparation, Sudarshana suspension on selected safety bio-markers in healthy adult volunteers?

Type of study


Study design


Single arm study


Masking not used







Study Phase

Phase 1

Intervention(s) planned

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.

Participants will receive approximately 37ml of the novel preparation at six hourly intervals (four daily doses) for 7 consecutive days. Dose calculation will be based on body weight (10/16 x 60kg body weight = 37 ml)

Sudarshana Powder (SP) mixed with and bees honey according to Ayurveda Authentic texts will be used in this novel preparation. No other excipients will be used.

Sudarshana Powder contains Andrographis paniculata (Burm. F.) Nees (50%) along with other 52 ingredients (50%), and is prepared according to the standard Ayurvedic formulation.

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

Primary outcome(s)


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 outcome(s)


After successive intervention of phase I , phase II studies will be planned according to ERC approval.


At baseline, day 3 and day 8


Target number/sample size

35 (Statistically determined)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status

Complete: follow up complete

Funding source

HETC project ,Ministry of Higher Education– CMB/IIM/N4

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number

775 /13

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
Institutional Address:Gangodawila, Nugegoda Sri Lanka
Telephone:+94-112758000 (Extension: 4075)
Email: erc.fms.usjp@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. W.A.S.S.Weerakoon
Lecturer and Consultant Ayurvedic Paediatrician
Department of Ayurveda Paediatrics, Institute of Indigenous Medicine, University of Colombo
Tel: 0112694308
Mob: 0714500031


Contact Person for Public Queries

Dr. T.S.Suresh
Senior Lecturer Grade I
Depart of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewardenepura
Tel: 0112758594
Mob: 0777314565


Primary study sponsor/organization

HETC Project, Ministry of Higher Education
Higher Education for 21st Century Project
Address 23 /135, Diyawanna Gardens, Chandra Silva Mawatha, Nugegoda, Sri Lanka

Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results