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Completed

NCT Number: NCT05827484

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

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.

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Key information

Conditions

PRP Losartan Muscle Injury Sport Injury

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous platelets rich plasma

Biological

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

Autologous platelets rich plasma + oral LOSARTAN administration

Combination Product

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

Primary outcomes

  1. ecchymosis

    Time frame: 1or 2 days after injury

    locally at the site of injury "present or absent"

  2. ecchymosis

    Time frame: 2 weeks after injury.

    locally at the site of injury "present or absent"

  3. ecchymosis

    Time frame: 1month after injury.

    locally at the site of injury "present or absent"

  4. ecchymosis

    Time frame: 3 months after injury.

    locally at the site of injury "present or absent"

  5. deformity

    Time frame: 1 or 2 days after injury

    palpable defects at the site of injury "present or absent"

  6. deformity

    Time frame: 2 weeks after injury.

    palpable defects at the site of injury "present or absent"

  7. deformity

    Time frame: 1month after injury.

    palpable defects at the site of injury "present or absent"

  8. deformity

    Time frame: 3 months after injury.

    palpable defects at the site of injury "present or absent"

  9. tenderness

    Time frame: 1 or 2 days after injury

    at the site of injury "present or absent"

  10. tenderness

    Time frame: 2 weeks after injury.

    at the site of injury "present or absent"

  11. tenderness

    Time frame: 1month after injury.

    at the site of injury "present or absent"

  12. tenderness

    Time frame: 3 months after injury.

    at the site of injury "present or absent"

  13. 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

  14. 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

  15. 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

  16. 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

  17. spasm

    Time frame: 1or 2 days after injury.

    spasm in the injured muscle "present or absent"

  18. spasm

    Time frame: 2 weeks after injury.

    spasm in the injured muscle "present or absent"

  19. spasm

    Time frame: 1month after injury.

    spasm in the injured muscle "present or absent"

  20. spasm

    Time frame: 3 months after injury.

    spasm in the injured muscle "present or absent"

  21. Pain with active muscle stretches

    Time frame: 1or 2 days after injury.

    "present or absent"

  22. Pain with active muscle stretches

    Time frame: 2 weeks after injury.

    "present or absent"

  23. Pain with active muscle stretches

    Time frame: 1month after injury.

    "present or absent"

  24. Pain with active muscle stretches

    Time frame: 3 months after injury.

    "present or absent"

  25. Pain with passive muscle stretches

    Time frame: 1 or 2 days after injury.

    "present or absent"

  26. Pain with passive muscle stretches

    Time frame: 2 weeks after injury.

    "present or absent"

  27. pain with passive muscle stretches

    Time frame: 3 months after injury.

    "present or absent"

  28. Pain with passive muscle stretches

    Time frame: 1month after injury.

    "present or absent"

  29. pain with active muscle contraction

    Time frame: 1 or 2 days after injury.

    "present or absent"

  30. pain with active muscle contraction

    Time frame: 2 weeks after injury.

    "present or absent"

  31. pain with active muscle contraction

    Time frame: 1month after injury.

    "present or absent"

  32. pain with active muscle contraction

    Time frame: 3 months after injury.

    "present or absent"

  33. pain with against resistance muscle contraction

    Time frame: 1 or 2 days after injury.

    "present or absent"

  34. pain with against resistance muscle contraction

    Time frame: 2 weeks after injury.

    "present or absent"

  35. pain with against resistance muscle contraction

    Time frame: 1month after injury.

    "present or absent"

  36. pain with against resistance muscle contraction

    Time frame: 3 months after injury.

    "present or absent"

  37. size of injury

    Time frame: 1 or 2 days after injury.

    in cm2 using ultrasound

  38. size of injury

    Time frame: 2 weeks after injury.

    in cm2 using ultrasound

  39. size of injury

    Time frame: 1month after injury.

    in cm2 using ultrasound

  40. size of injury

    Time frame: 3 months after injury.

    in cm2 using ultrasound

  41. disorganized fibrous tissue

    Time frame: 1 or 2 days after injury.

    "present or absent" using ultrasound

  42. disorganized fibrous tissue

    Time frame: 2 weeks after injury.

    "present or absent" using ultrasound

  43. disorganized fibrous tissue

    Time frame: 1month after injury.

    "present or absent" using ultrasound

  44. disorganized fibrous tissue

    Time frame: 3 months after injury.

    "present or absent" using ultrasound

  45. hematoma

    Time frame: 1 or 2 days after injury.

    "present or absent" using ultrasound

  46. hematoma

    Time frame: 2 weeks after injury.

    "present or absent" using ultrasound

  47. hematoma

    Time frame: 1month after injury.

    "present or absent" using ultrasound

  48. hematoma

    Time frame: 3 months after injury.

    "present or absent" using ultrasound

  49. Doppler signal

    Time frame: 1 or 2 days after injury.

    "present or absent" using ultrasound

  50. Doppler signal

    Time frame: 2 weeks after injury.

    "present or absent" using ultrasound

  51. Doppler signal

    Time frame: 1month after injury.

    "present or absent" using ultrasound

  52. Doppler signal

    Time frame: 3 months after injury.

    "present or absent" using ultrasound

Sponsors and collaborators

Lead sponsor

Mostafa Hassanein, Msc

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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