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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04456907
Other study ID # 6501714
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2017
Est. completion date March 28, 2018

Study information

Verified date March 2017
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective Platelet-rich plasma (PRP) is widely utilized in the treatment of sports injuries with favorable outcomes. However, potential systemic effects after localized PRP injection are unclear at present.

Design: prospective randomized study Methods Twenty-four Taiwanese male athletes with tendinopathy were randomized into a PRP group (n = 13) or a saline group (n = 11).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 28, 2018
Est. primary completion date November 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria

- Adult male athletes were diagnosed with tendinitis

Exclusion Criteria:

- Receive local injections and surgery within three months

- Systemic disease

- Diagnosis of anemia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
platelet rich plasma
Autologous platelet-rich plasma (PRP) was prepared using the RegenKit THT system (RegenLab SA, Le Mont-sur-Lausanne, Switzerland) following the manufacturer's instructions. Medical technicians, who had been well-trained by the manufacturer, were responsible for the process of PRP preparation. For each patient, 8-10 mL of venous blood was drawn and collected to the commercial RegnLab THT tube, which contained 1 mL sodium citrate. After single centrifugation at 3400 revolutions per minute (rpm) for 8 minutes, 4-5 mL of PRP was yielded with leukocytes maintained at physiological levels and red blood cells depleted. Then, the blood components were separated, with the platelet pellet resting on the separating gel. PRP for later application was obtained by re-suspending the platelet pellet in the plasma supernatant by gently inverting the unopened RegenKit THT tube 5 to 10 times.
saline injection
saline injection

Locations

Country Name City State
Taiwan Chang Gung Medical Hosptial Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary excretion of endogenous AAS metabolites Doping substances in urine, mainly metabolites of anabolic androgenic steroids (AAS), were quantified, including testosterone (17ß-hydroxyandrost-4-en-3-one), epitestosterone (17a- hydroxy-4-androsten-3-one), androsterone (4-androsten-3,17-dione), etiocholanolone (3a-hydroxy-5ß-androstan-17-one), DHEA (dehydroepiandrosterone), dihydroandrosterone (5a- androstane-3a,17ß-diol), and etiocholane-3a,17ß-diol (5ß -androstane-3a,17ß-diol). Each urine sample (6 mL) was mixed with 50 µL standard solution and 1 mL phosphate buffer, and the mixture was heated for 60 min at 50°C. After cooling at room temperature, liquid-liquid extraction was performed, and phase separation was achieved. The organic extract was evaporated to dryness, and the dried residue was further derivatized with 50 µL of MSTFA solution for 30 min at 60°C. Finally, the sample was subjected to gas chromatographic analysis and mass spectrometric analysis for quantification of doping substances of interest. 1 week