Home » Trials » SLCTR/2015/026

Therapeutic evaluation of the antipyretic activity of the Ayurvedic preparation Sudarshana Suspension in febrile children.


SLCTR Registration Number


Date of Registration

19 Nov 2015

The date of last modification

Nov 13, 2020

Trial Status

Application Summary

Scientific Title of Trial

Therapeutic evaluation of the antipyretic activity of the Ayurvedic preparation Sudarshana Suspension in febrile children.

Public Title of Trial

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

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


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

Ref No: 12/11 Ethics Review Committee, Institute of Indigenous Medicine [ERCIIM], University of Colombo; Ref. No.18/15 Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura.

Trial Details

What is the research question being addressed?

What is the antipyretic efficacy and palatability of the novel preparation Sudarshana suspension compared to Sudarshana powder in febrile children?

Type of study


Study design


Non-randomized controlled trial


Single blinded


Standard therapy/practice





Study Phase

Phase 2

Intervention(s) planned

Patients with fever, between 6-12 years out of the admitted patients to the hospital and from the Out Patient Department (OPD) of Paediatrics clinics at the Ayurvedic Teaching Hospital, Borella, will be selected irrespective of their sex. Systematic sampling will be used to allocate patients meeting the inclusion/exclusion criteria into two arms.

Arm A (intervention arm): Sudarshana suspension(n=50) Arm B (control arm): Sudarshana Powder with bee honey (n=50)

Dosage will be calculated according to the Ayurvedic authentic text dosage of Sudarshana Suspension as calculated as 312.5mg/kg/ 24 hours.

Medication will be administered orally six hourly, up to four doses in each 24 hour period, for a maximum of three days (12 doses) by the trained nursing staff under the observation of a medical officer.

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.

Primary outcome(s)

  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)

  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 )
  1. Within the first 6 hours following administration

  2. At the end of three days or at complete resolution of the fever.


Secondary outcome(s)


Palatability of medications using a five point scale


Immediately following the first dose and at the end of 6 hours


Target number/sample size

100 (50 in each arm)

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


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 Sri Lanka
Tel: 0112694308
Mob: 0714500031


Contact Person for Public Queries

Prof. Dulani Gunasekera
Associate Professor in Paediatrics
Department of Paediatrics, Faculty of Medical Sciences, University of Sri Jayawardenepura Sri Lanka

Mob: 0714049531


Primary study sponsor/organization

HETC Project, Ministry of Higher Education
Higher Education for 21st Century Project
No. 23 /135, Diyawanna Gardens, Chandra Silva Mawatha, Nugegoda, Sri Lanka
Tel: 00941122852266
Fax: 0094112814283

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