Home » Trials » SLCTR/2020/008


Effectiveness of Oral Serratiopeptidase in Reduction of Lower Limb Cellulitis: A randomized controlled study

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SLCTR Registration Number

SLCTR/2020/008


Date of Registration

11 Feb 2020

The date of last modification

Feb 12, 2020



Application Summary


Scientific Title of Trial

Effectiveness of Oral Serratiopeptidase in Reduction of Lower Limb Cellulitis: A randomized controlled study


Public Title of Trial

Effectiveness of a selected oral serratiopeptidase in the market in reduction of the lower limb girth of patients with lower limb swelling due to cellulitis


Disease or Health Condition(s) Studied

cellulitis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1236-9334


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

EC–18–067 ERC Colombo


Trial Details


What is the research question being addressed?

Does selected oral serratiopeptidase supplements reduce the lower limb girth of patients with lower limb swelling due to cellulitis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Other


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

All consecutive patients who are admitted to the National Hospital Sri Lanka ward 27 and 38 with lower limb cellulitis will be recruited according to inclusion / exclusion criteria. Patients will be allocated into case (drug given) and control (drug not given) groups according to a computer generated number randomization. Case group will be given a selected oral serropeptidase inhibitor already available in the market (Brand names: IMOI or SEROFLAME) 15mg bd for 10 days on top of standard therapy [Benzylpenicillin 2.4g IV, 4 hourly for five days] Control group will only receive standard therapy. Limb circumference will be measured in both groups on admission and on third and tenth day since admission.


Inclusion criteria

• Both males and females • Above 18 years of age • Diagnosed with lower limb cellulitis


Exclusion criteria

• Patients who are on anti-coagulants • Patients with other significant co-morbidities – congestive heart failure, chronic renal impairment • Patients who have received antibiotics during this episode prior to this admission. • Patients with preexisting lymphedema • Patients who are hypersensitive to penicillin and / or cloxacillin • Patients who present with septic shock



Primary outcome(s)

1.

Limb circumference will be measured on admission using a tape measurement method

[

On admission, day 3 and 10 days after admission.

]

Secondary outcome(s)

1.

None

[]

Target number/sample size

110 (55 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2020-02-11


Anticipated end date

2020-06-11


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-05-16


Approval number

EC-18-067


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo.
Institutional Address:P.O. Box 271, Kynsy Road, Colombo 8, Sri lanka
Telephone:+94112695300
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Nadun Lakshitha Mohotti
Doctor
NHSL colombo
0112691111
0777634452

nadun1983@gmail.com

Contact Person for Public Queries

Dr A N K Abayajeewa
Consultant General Surgeon
NHSL colombo
0112691111
0776600266

kirthi35@hotmail.com


Primary study sponsor/organization

NHSL, Colombo





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


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results