Clinical trial

A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP

Name

FMASU MS 22/2016

Description

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.

Trial arms

Trial start

2016-10-10

Estimated PCD

2017-09-05

Trial end

2017-12-12

Status

Completed

Phase

Early phase I

Treatment

Autologous platelets rich plasma

30 ml of venous blood were drawn from the participant by means of venipuncture. The collected blood was mixed with 3 ml anti-coagulant acid citrate dextrose in the centrifugation sterile tube. The blood sample was then centrifuged using the centrifugation machine. 3 ml of PRP from the buffy coat layer were loaded in a 5 ml syringe. After local sterilization and draping of the site of injection and under US guidance the hematoma was aspirated from the injury site and the freshly prepared PRP was injected.

Arms:

10 patients with acute skeletal muscle injury underwent PRP injection

Other names:

PRP

Autologous platelets rich plasma + oral LOSARTAN administration

in addition to local PRP injection, 50 mg / day of LOSARTAN (Cozaar® 50 mg film-coated tablets) were administrated to the study group orally every morning from day 5 and till day 30 after injury.

Arms:

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

Other names:

PRP + LOSARTAN

Size

Primary endpoint

ecchymosis

1or 2 days after injury

ecchymosis

2 weeks after injury.

ecchymosis

1month after injury.

ecchymosis

3 months after injury.

deformity

1 or 2 days after injury

deformity

2 weeks after injury.

deformity

1month after injury.

deformity

3 months after injury.

tenderness

1 or 2 days after injury

tenderness

2 weeks after injury.

tenderness

1month after injury.

tenderness

3 months after injury.

Pain at site of injury

1 or 2 days after injury

Pain at site of injury

2 weeks after injury.

Pain at site of injury

1month after injury.

Pain at site of injury

3 months after injury.

spasm

1or 2 days after injury.

spasm

2 weeks after injury.

spasm

1month after injury.

spasm

3 months after injury.

Pain with active muscle stretches

1or 2 days after injury.

Pain with active muscle stretches

2 weeks after injury.

Pain with active muscle stretches

1month after injury.

Pain with active muscle stretches

3 months after injury.

Pain with passive muscle stretches

1 or 2 days after injury.

Pain with passive muscle stretches

2 weeks after injury.

pain with passive muscle stretches

3 months after injury.

Pain with passive muscle stretches

1month after injury.

pain with active muscle contraction

1 or 2 days after injury.

pain with active muscle contraction

2 weeks after injury.

pain with active muscle contraction

1month after injury.

pain with active muscle contraction

3 months after injury.

pain with against resistance muscle contraction

1 or 2 days after injury.

pain with against resistance muscle contraction

2 weeks after injury.

pain with against resistance muscle contraction

1month after injury.

pain with against resistance muscle contraction

3 months after injury.

size of injury

1 or 2 days after injury.

size of injury

2 weeks after injury.

size of injury

1month after injury.

size of injury

3 months after injury.

disorganized fibrous tissue

1 or 2 days after injury.

disorganized fibrous tissue

2 weeks after injury.

disorganized fibrous tissue

1month after injury.

disorganized fibrous tissue

3 months after injury.

hematoma

1 or 2 days after injury.

hematoma

2 weeks after injury.

hematoma

1month after injury.

hematoma

3 months after injury.

Doppler signal

1 or 2 days after injury.

Doppler signal

2 weeks after injury.

Doppler signal

1month after injury.

Doppler signal

3 months after injury.

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-07-14

1 organization

2 products

4 indications

Organization

Mostafa Hassanein, Msc

Product

Autologous Platelet Rich Plasma

Indication

Indication

Indication

Indication

Product

Autologous platelets rich plasma + Losartan