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
The date of last modification
Sep 10, 2020
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
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
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 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
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
