PRPPhase 4NCT05827484

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

A Phase 4 study testing Autologous platelets rich plasma and Autologous platelets rich plasma + oral LOSARTAN administration in people with PRP and Losartan, run by Mostafa Hassanein, Msc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: PRP, Losartan, Muscle Injury
What is being tested?: Autologous platelets rich plasma and Autologous platelets rich plasma + oral LOSARTAN administration
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 10 Oct 2016to 12 Dec 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Show all 11Show fewer

No detectable injury ultrasonographically.
Anemia
Thrombocytopenia or any platelet disorder.
Pregnancy or lactation.
Local infection

About this study

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

Conditions: PRP, Losartan, Muscle Injury, Sport Injury
Being tested: Autologous platelets rich plasma, Autologous platelets rich plasma + oral LOSARTAN administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous platelets rich plasmaBiological
Also called PRP
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.
Autologous platelets rich plasma + oral LOSARTAN administrationCombination product
Also called PRP + LOSARTAN
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.

Study groups in NCT05827484
Study group	Role	What they receive
10 patients with acute skeletal muscle injury underwent PRP injection	Active comparator	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. Receives: Biological: Autologous platelets rich plasma
10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN	Experimental	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. Receives: Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration

What is being measured

The primary outcome is the main question the study is designed to answer.

ecchymosis
locally at the site of injury "present or absent"
Measured: 1or 2 days after injury
ecchymosis
locally at the site of injury "present or absent"
Measured: 2 weeks after injury.
ecchymosis
locally at the site of injury "present or absent"
Measured: 1month after injury.
ecchymosis
locally at the site of injury "present or absent"
Measured: 3 months after injury.
deformity
palpable defects at the site of injury "present or absent"
Measured: 1 or 2 days after injury
deformity
palpable defects at the site of injury "present or absent"
Measured: 2 weeks after injury.
deformity
palpable defects at the site of injury "present or absent"
Measured: 1month after injury.
deformity
palpable defects at the site of injury "present or absent"
Measured: 3 months after injury.
tenderness
at the site of injury "present or absent"
Measured: 1 or 2 days after injury
tenderness
at the site of injury "present or absent"
Measured: 2 weeks after injury.
tenderness
at the site of injury "present or absent"
Measured: 1month after injury.
tenderness
at the site of injury "present or absent"
Measured: 3 months after injury.
Pain at site of injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Measured: 1 or 2 days after injury
Pain at site of injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Measured: 2 weeks after injury.
Pain at site of injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Measured: 1month after injury.
Pain at site of injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Measured: 3 months after injury.
spasm
spasm in the injured muscle "present or absent"
Measured: 1or 2 days after injury.
spasm
spasm in the injured muscle "present or absent"
Measured: 2 weeks after injury.
spasm
spasm in the injured muscle "present or absent"
Measured: 1month after injury.
spasm
spasm in the injured muscle "present or absent"
Measured: 3 months after injury.
Pain with active muscle stretches
"present or absent"
Measured: 1or 2 days after injury.
Pain with active muscle stretches
"present or absent"
Measured: 2 weeks after injury.
Pain with active muscle stretches
"present or absent"
Measured: 1month after injury.
Pain with active muscle stretches
"present or absent"
Measured: 3 months after injury.
Pain with passive muscle stretches
"present or absent"
Measured: 1 or 2 days after injury.
Pain with passive muscle stretches
"present or absent"
Measured: 2 weeks after injury.
pain with passive muscle stretches
"present or absent"
Measured: 3 months after injury.
Pain with passive muscle stretches
"present or absent"
Measured: 1month after injury.
pain with active muscle contraction
"present or absent"
Measured: 1 or 2 days after injury.
pain with active muscle contraction
"present or absent"
Measured: 2 weeks after injury.
pain with active muscle contraction
"present or absent"
Measured: 1month after injury.
pain with active muscle contraction
"present or absent"
Measured: 3 months after injury.
pain with against resistance muscle contraction
"present or absent"
Measured: 1 or 2 days after injury.
pain with against resistance muscle contraction
"present or absent"
Measured: 2 weeks after injury.
pain with against resistance muscle contraction
"present or absent"
Measured: 1month after injury.
pain with against resistance muscle contraction
"present or absent"
Measured: 3 months after injury.
size of injury
in cm2 using ultrasound
Measured: 1 or 2 days after injury.
size of injury
in cm2 using ultrasound
Measured: 2 weeks after injury.
size of injury
in cm2 using ultrasound
Measured: 1month after injury.
size of injury
in cm2 using ultrasound
Measured: 3 months after injury.
disorganized fibrous tissue
"present or absent" using ultrasound
Measured: 1 or 2 days after injury.
disorganized fibrous tissue
"present or absent" using ultrasound
Measured: 2 weeks after injury.
disorganized fibrous tissue
"present or absent" using ultrasound
Measured: 1month after injury.
disorganized fibrous tissue
"present or absent" using ultrasound
Measured: 3 months after injury.
hematoma
"present or absent" using ultrasound
Measured: 1 or 2 days after injury.
hematoma
"present or absent" using ultrasound
Measured: 2 weeks after injury.
hematoma
"present or absent" using ultrasound
Measured: 1month after injury.
hematoma
"present or absent" using ultrasound
Measured: 3 months after injury.
Doppler signal
"present or absent" using ultrasound
Measured: 1 or 2 days after injury.
Doppler signal
"present or absent" using ultrasound
Measured: 2 weeks after injury.
Doppler signal
"present or absent" using ultrasound
Measured: 1month after injury.
Doppler signal
"present or absent" using ultrasound
Measured: 3 months after injury.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201612 Dec 2017

First posted25 Apr 2023
Study start10 Oct 2016
Primary completion5 Sep 2017
Study completion12 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PRPStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05827484
Sponsor's protocol ID: FMASU MS 22/2016
Status last verified: Jul 2023
First submitted: 1 Apr 2023
Last updated: 14 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Woodhouse JB, McNally EG. Ultrasound of skeletal muscle injury: an update. Semin Ultrasound CT MR. 2011 Apr;32(2):91-100. doi: 10.1053/j.sult.2010.12.002.
PubMed 21414545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP
ClinicalTrials.gov ID: NCT05827484
Acronym / sponsor ID: FMASU MS 22/2016
Conditions: PRP, Losartan, Muscle Injury, Sport Injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Mostafa Hassanein, MscUniversity, hospital or other
Study start: 10 Oct 2016 (actual)
Primary completion: 5 Sep 2017 (actual)
Study completion: 12 Dec 2017 (actual)
First posted: 25 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
10 patients with acute skeletal muscle injury underwent PRP injection	Active comparator	Biological: Autologous platelets rich plasmaPatients 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.
10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN	Experimental	Combination Product: Autologous platelets rich plasma + oral LOSARTAN administrationPatients 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous platelets rich plasmaAlso: PRP30 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.	Biological	10 patients with acute skeletal muscle injury underwent PRP injection
Autologous platelets rich plasma + oral LOSARTAN administrationAlso: PRP + LOSARTANin 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.	Combination product	10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN

Primary outcome

ecchymosis
Time frame: 1or 2 days after injury
locally at the site of injury "present or absent"
ecchymosis
Time frame: 2 weeks after injury.
locally at the site of injury "present or absent"
ecchymosis
Time frame: 1month after injury.
locally at the site of injury "present or absent"
ecchymosis
Time frame: 3 months after injury.
locally at the site of injury "present or absent"
deformity
Time frame: 1 or 2 days after injury
palpable defects at the site of injury "present or absent"
deformity
Time frame: 2 weeks after injury.
palpable defects at the site of injury "present or absent"
deformity
Time frame: 1month after injury.
palpable defects at the site of injury "present or absent"
deformity
Time frame: 3 months after injury.
palpable defects at the site of injury "present or absent"
tenderness
Time frame: 1 or 2 days after injury
at the site of injury "present or absent"
tenderness
Time frame: 2 weeks after injury.
at the site of injury "present or absent"
tenderness
Time frame: 1month after injury.
at the site of injury "present or absent"
tenderness
Time frame: 3 months after injury.
at the site of injury "present or absent"
Pain at site of injury
Time frame: 1 or 2 days after injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Pain at site of injury
Time frame: 2 weeks after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Pain at site of injury
Time frame: 1month after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Pain at site of injury
Time frame: 3 months after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
spasm
Time frame: 1or 2 days after injury.
spasm in the injured muscle "present or absent"
spasm
Time frame: 2 weeks after injury.
spasm in the injured muscle "present or absent"
spasm
Time frame: 1month after injury.
spasm in the injured muscle "present or absent"
spasm
Time frame: 3 months after injury.
spasm in the injured muscle "present or absent"
Pain with active muscle stretches
Time frame: 1or 2 days after injury.
"present or absent"
Pain with active muscle stretches
Time frame: 2 weeks after injury.
"present or absent"
Pain with active muscle stretches
Time frame: 1month after injury.
"present or absent"
Pain with active muscle stretches
Time frame: 3 months after injury.
"present or absent"
Pain with passive muscle stretches
Time frame: 1 or 2 days after injury.
"present or absent"
Pain with passive muscle stretches
Time frame: 2 weeks after injury.
"present or absent"
pain with passive muscle stretches
Time frame: 3 months after injury.
"present or absent"
Pain with passive muscle stretches
Time frame: 1month after injury.
"present or absent"
pain with active muscle contraction
Time frame: 1 or 2 days after injury.
"present or absent"
pain with active muscle contraction
Time frame: 2 weeks after injury.
"present or absent"
pain with active muscle contraction
Time frame: 1month after injury.
"present or absent"
pain with active muscle contraction
Time frame: 3 months after injury.
"present or absent"
pain with against resistance muscle contraction
Time frame: 1 or 2 days after injury.
"present or absent"
pain with against resistance muscle contraction
Time frame: 2 weeks after injury.
"present or absent"
pain with against resistance muscle contraction
Time frame: 1month after injury.
"present or absent"
pain with against resistance muscle contraction
Time frame: 3 months after injury.
"present or absent"
size of injury
Time frame: 1 or 2 days after injury.
in cm2 using ultrasound
size of injury
Time frame: 2 weeks after injury.
in cm2 using ultrasound
size of injury
Time frame: 1month after injury.
in cm2 using ultrasound
size of injury
Time frame: 3 months after injury.
in cm2 using ultrasound
disorganized fibrous tissue
Time frame: 1 or 2 days after injury.
"present or absent" using ultrasound
disorganized fibrous tissue
Time frame: 2 weeks after injury.
"present or absent" using ultrasound
disorganized fibrous tissue
Time frame: 1month after injury.
"present or absent" using ultrasound
disorganized fibrous tissue
Time frame: 3 months after injury.
"present or absent" using ultrasound
hematoma
Time frame: 1 or 2 days after injury.
"present or absent" using ultrasound
hematoma
Time frame: 2 weeks after injury.
"present or absent" using ultrasound
hematoma
Time frame: 1month after injury.
"present or absent" using ultrasound
hematoma
Time frame: 3 months after injury.
"present or absent" using ultrasound
Doppler signal
Time frame: 1 or 2 days after injury.
"present or absent" using ultrasound
Doppler signal
Time frame: 2 weeks after injury.
"present or absent" using ultrasound
Doppler signal
Time frame: 1month after injury.
"present or absent" using ultrasound
Doppler signal
Time frame: 3 months after injury.
"present or absent" using ultrasound

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
Background: PubMed 21414545Woodhouse JB, McNally EG. Ultrasound of skeletal muscle injury: an update. Semin Ultrasound CT MR. 2011 Apr;32(2):91-100. doi: 10.1053/j.sult.2010.12.002.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mostafa M. Hassanein, Msc principal investigator

Ain Shams University

Wael A.M. Nassar, MD study director

Ain Shams University

Medhat M. Magdy, Msc principal investigator

Ain Shams University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Autologous platelets rich plasma and Autologous platelets rich plasma + oral LOSARTAN administration in people with PRP and Losartan, run by Mostafa Hassanein, Msc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ecchymosis (time frame: 1or 2 days after injury). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.