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

July 13, 2023 updated by: Mostafa Hassanein, Msc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 10 patients with acute skeletal muscle injury underwent PRP injection
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.
Biological: 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.
Other Names:
  • PRP
Experimental: 10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN
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.
Combination product: 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.
Other Names:
  • PRP + LOSARTAN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ecchymosis
Time Frame: 1or 2 days after injury
locally at the site of injury "present or absent"
1or 2 days after injury
ecchymosis
Time Frame: 2 weeks after injury.
locally at the site of injury "present or absent"
2 weeks after injury.
ecchymosis
Time Frame: 1month after injury.
locally at the site of injury "present or absent"
1month after injury.
ecchymosis
Time Frame: 3 months after injury.
locally at the site of injury "present or absent"
3 months after injury.
deformity
Time Frame: 1 or 2 days after injury
palpable defects at the site of injury "present or absent"
1 or 2 days after injury
deformity
Time Frame: 2 weeks after injury.
palpable defects at the site of injury "present or absent"
2 weeks after injury.
deformity
Time Frame: 1month after injury.
palpable defects at the site of injury "present or absent"
1month after injury.
deformity
Time Frame: 3 months after injury.
palpable defects at the site of injury "present or absent"
3 months after injury.
tenderness
Time Frame: 1 or 2 days after injury
at the site of injury "present or absent"
1 or 2 days after injury
tenderness
Time Frame: 2 weeks after injury.
at the site of injury "present or absent"
2 weeks after injury.
tenderness
Time Frame: 1month after injury.
at the site of injury "present or absent"
1month after injury.
tenderness
Time Frame: 3 months after injury.
at the site of injury "present or absent"
3 months after injury.
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
1 or 2 days after injury
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
2 weeks after injury.
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
1month after injury.
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
3 months after injury.
spasm
Time Frame: 1or 2 days after injury.
spasm in the injured muscle "present or absent"
1or 2 days after injury.
spasm
Time Frame: 2 weeks after injury.
spasm in the injured muscle "present or absent"
2 weeks after injury.
spasm
Time Frame: 1month after injury.
spasm in the injured muscle "present or absent"
1month after injury.
spasm
Time Frame: 3 months after injury.
spasm in the injured muscle "present or absent"
3 months after injury.
Pain with active muscle stretches
Time Frame: 1or 2 days after injury.
"present or absent"
1or 2 days after injury.
Pain with active muscle stretches
Time Frame: 2 weeks after injury.
"present or absent"
2 weeks after injury.
Pain with active muscle stretches
Time Frame: 1month after injury.
"present or absent"
1month after injury.
Pain with active muscle stretches
Time Frame: 3 months after injury.
"present or absent"
3 months after injury.
Pain with passive muscle stretches
Time Frame: 1 or 2 days after injury.
"present or absent"
1 or 2 days after injury.
Pain with passive muscle stretches
Time Frame: 2 weeks after injury.
"present or absent"
2 weeks after injury.
pain with passive muscle stretches
Time Frame: 3 months after injury.
"present or absent"
3 months after injury.
Pain with passive muscle stretches
Time Frame: 1month after injury.
"present or absent"
1month after injury.
pain with active muscle contraction
Time Frame: 1 or 2 days after injury.
"present or absent"
1 or 2 days after injury.
pain with active muscle contraction
Time Frame: 2 weeks after injury.
"present or absent"
2 weeks after injury.
pain with active muscle contraction
Time Frame: 1month after injury.
"present or absent"
1month after injury.
pain with active muscle contraction
Time Frame: 3 months after injury.
"present or absent"
3 months after injury.
pain with against resistance muscle contraction
Time Frame: 1 or 2 days after injury.
"present or absent"
1 or 2 days after injury.
pain with against resistance muscle contraction
Time Frame: 2 weeks after injury.
"present or absent"
2 weeks after injury.
pain with against resistance muscle contraction
Time Frame: 1month after injury.
"present or absent"
1month after injury.
pain with against resistance muscle contraction
Time Frame: 3 months after injury.
"present or absent"
3 months after injury.
size of injury
Time Frame: 1 or 2 days after injury.
in cm2 using ultrasound
1 or 2 days after injury.
size of injury
Time Frame: 2 weeks after injury.
in cm2 using ultrasound
2 weeks after injury.
size of injury
Time Frame: 1month after injury.
in cm2 using ultrasound
1month after injury.
size of injury
Time Frame: 3 months after injury.
in cm2 using ultrasound
3 months after injury.
disorganized fibrous tissue
Time Frame: 1 or 2 days after injury.
"present or absent" using ultrasound
1 or 2 days after injury.
disorganized fibrous tissue
Time Frame: 2 weeks after injury.
"present or absent" using ultrasound
2 weeks after injury.
disorganized fibrous tissue
Time Frame: 1month after injury.
"present or absent" using ultrasound
1month after injury.
disorganized fibrous tissue
Time Frame: 3 months after injury.
"present or absent" using ultrasound
3 months after injury.
hematoma
Time Frame: 1 or 2 days after injury.
"present or absent" using ultrasound
1 or 2 days after injury.
hematoma
Time Frame: 2 weeks after injury.
"present or absent" using ultrasound
2 weeks after injury.
hematoma
Time Frame: 1month after injury.
"present or absent" using ultrasound
1month after injury.
hematoma
Time Frame: 3 months after injury.
"present or absent" using ultrasound
3 months after injury.
Doppler signal
Time Frame: 1 or 2 days after injury.
"present or absent" using ultrasound
1 or 2 days after injury.
Doppler signal
Time Frame: 2 weeks after injury.
"present or absent" using ultrasound
2 weeks after injury.
Doppler signal
Time Frame: 1month after injury.
"present or absent" using ultrasound
1month after injury.
Doppler signal
Time Frame: 3 months after injury.
"present or absent" using ultrasound
3 months after injury.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mostafa Hassanein, Msc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mostafa M. Hassanein, Msc, Ain shams university hospitals
  • Study Director: Wael A.M. Nassar, MD, Ain shams university hospitals
  • Principal Investigator: Medhat M. Magdy, Msc, Ain shams university hospitals
  • Principal Investigator: Amr G. Gendya, MD, Ain shams university hospitals
  • Principal Investigator: Haitham Adel A. A. El Dessokey, MD, Ain shams university hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MS 22/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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