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Home » Trials » SLCTR/2015/026

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

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SLCTR Registration Number

SLCTR/2015/026

Date of Registration

19 Nov 2015

The date of last modification

Aug 26, 2022

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

Fever

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1167-0783

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

Interventional

Study design

Allocation

Non-randomized controlled trial

Masking

Single blinded

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

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.
  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)

1.

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

2015-11-20

Anticipated end date

2016-03-10

Date of first enrollment

2015-11-05

Date of study completion

2016-06-22

Recruitment status

Complete: follow up complete

Funding source

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

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2015-10-29

Approval number

18/15

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

sarojaweerakoon@yahoo.com

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

dulaniegunasekera@yahoo.com

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
ppdu@hetc.lk
www.hetc.lk

Secondary study sponsor (If any)

None





Trial Completion details

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

No

IPD sharing plan description

No

Study protocol available

Yes

Protocol version and date

Final version submitted to ERC

Protocol URL

Not published

Results summary available

Yes

Date of posting results

2018-07-20

Date of study completion

2016-06-22

Final sample size

42 ( 21 in each arm)

Date of first publication

2017-07-10

Link to results

Weerakoon WASS, Perera PK, Gunasekara D. and Suresh TS: Antipyretic effect of novel preparation Sudarshana suspension in febrile children. 3rd International Conference on Natural products Genomics and Drug Discovery; Colombo, Sri Lanka at Galadari Hotel,

Brief summary of results

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).


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