NCT04886882

Brief Summary

An experimental study examining wound healing in 5 different groups on 30 rats.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 13, 2021

Last Update Submit

May 10, 2021

Conditions

Keywords

magnesium sulphatewound healing rat modelhydroxyproline

Outcome Measures

Primary Outcomes (1)

  • 7th day evaluation

    Histopathological evaluation of wound healing comparing with the rate of vascular endothelial growth factor (VEGF), transforming growth factor (TGF-beta) and hydroxyproline at immunohistochemical staining with biopsy on the 7th day.

    7th day

Secondary Outcomes (1)

  • 15th day evaluation

    15th day

Study Arms (5)

Group placebo

PLACEBO COMPARATOR

Isotonic solution will be administered daily to 6 female rats.

Other: placebo comparator

Group sham

SHAM COMPARATOR

Base cream to be applied twice a day to 6 female rats.

Other: sham comparator

Group %1 mgso4

EXPERIMENTAL

Cream containing 1% MgSO4 will be applied twice a day to 6 female rats.

Other: Experimental drug 1

Group %10 MgSO4

EXPERIMENTAL

Cream containing 10% MgSO4 will be applied twice a day to 6 female rats.

Other: Experimental drug 2

Group positive control

ACTIVE COMPARATOR

Cream containing centella asiatica will be applied twice a day to 6 female rats.

Drug: Centella asiatica

Interventions

solution containing 0.9 % sodium chlorine

Group placebo

vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water

Group sham

A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water

Group %1 mgso4

A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water

Group %10 MgSO4

A cream containing Centella asiatica

Group positive control

Eligibility Criteria

Age8 Weeks - 12 Weeks
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy rats between ages of 8- 12 weeks

You may not qualify if:

  • weight loss of more than 15% of body weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam Ve Sakura Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Centella asiatica extract

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

May 14, 2021

Study Start

March 22, 2021

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

May 14, 2021

Record last verified: 2021-04

Locations