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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05827484
Other study ID # FMASU MS 22/2016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 10, 2016
Est. completion date December 12, 2017

Study information

Verified date July 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 rich plasma.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 12, 2017
Est. primary completion date September 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mostafa Hassanein, Msc

References & Publications (1)

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. — View Citation

Outcome

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