The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

Mostafa Hassanein, Msc

Status and phase: Completed; Phase 4

Conditions: Muscle Injury; Losartan; PRP; Sport Injury

Treatments: Biological: Autologous platelets rich plasma; Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05827484

FMASU MS 22/2016

Details and patient eligibility

About

The aim of this comparative study is to determine whether or not LOSARTAN with its anti-fibrotic action has an added effect when administrated with platelet rich plasma injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries in comparison with the sole administration of platelet rich plasma.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult age. (18 - 40 year old).
• Clinically diagnosed acute skeletal muscle injury with maximum 3 days duration and ultrasonographically confirmed grade II according to Woodhouse et al.
• Understanding the study and accepting the participation

Exclusion criteria

• Any connective tissue disease (e.g. rheumatoid arthritis, systemic lupus erythematous, etc.)
• Hypertension or hypotension
• Diabetes mellitus
• Any cardiac or pulmonary disease
• NSAIDs use in less than a week prior to the beginning of the study.
• Muscle injuries requiring surgical interference.
• No detectable injury ultrasonographically.
• Anemia
• Thrombocytopenia or any platelet disorder.
• Pregnancy or lactation.
• Local infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

10 patients with acute skeletal muscle injury underwent PRP injection

Active Comparator group

Description:

Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in the site of injury in day 1 or 2 of the injury.

Treatment:

Biological: Autologous platelets rich plasma

10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN

Experimental group

Description:

Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in day 1 or 2 of injury in addition to administration of oral (50mg LOSARTAN /day) from day 5 to day 30.

Treatment:

Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration