Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925725
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-04-07
Brief Title:
Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at Patients With Knee Arthrosis
Sponsor:
Polyclinic of the Hospitaller Brothers of St John of God Budapest
Organization:
Polyclinic of the Hospitaller Brothers of St John of God Budapest
Study Overview
Official Title:
Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at the Treatment of Patients With Knee Arthrosis A Multicenter Randomized Double-blind Follow-up Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be a multicenter randomized double-blind follow-up clinical trial
Neither the examining doctor nor the patient knows which capsule they will receive Just the test unlock the codes after completion T
Neither the examining doctor nor the patient knows which capsule they will receive Just the test unlock the codes after completion T
Detailed Description:
The study will be a multicenter randomized double-blind follow-up clinical trial
Neither the examining doctor nor the patient knows which capsule they will receive Just the test unlock the codes after completion The randomization was performed externally not included in the study performed by a person Number of patients a total of 105 patients 25-25 per clinic with 8 patients each in three treatment groups Three treatment groups
35 people physical therapy Loxacon
35 main physical therapy Placebo
35 people only for physical therapy Physiotherapyexercise takes place according to a uniform protocol Physiotherapy 2x30 minutes per week for 5 weeks 10 times in total The course of the investigation
1 st visit selection filling in questionnaires
2 nd visit after the 10th exercise session while taking Loxaconplacebo filling in questionnaires
3 rd visit Uniformly after another 2 months of taking Loxacon in all three groups completing questionnaires After the first 5 weeks all three branches will receive enough Loxacon capsules for 2 months The parameters to be tested
WOMAC test
VAS
EQ-5D-5L quality of life test
Goniometer angle measurement The test is completed by patients who participated in more than 70 of the treatment Monitoring of side effects It is the duty of the doctor of the given center - who reports to the investigator
Neither the examining doctor nor the patient knows which capsule they will receive Just the test unlock the codes after completion The randomization was performed externally not included in the study performed by a person Number of patients a total of 105 patients 25-25 per clinic with 8 patients each in three treatment groups Three treatment groups
35 people physical therapy Loxacon
35 main physical therapy Placebo
35 people only for physical therapy Physiotherapyexercise takes place according to a uniform protocol Physiotherapy 2x30 minutes per week for 5 weeks 10 times in total The course of the investigation
1 st visit selection filling in questionnaires
2 nd visit after the 10th exercise session while taking Loxaconplacebo filling in questionnaires
3 rd visit Uniformly after another 2 months of taking Loxacon in all three groups completing questionnaires After the first 5 weeks all three branches will receive enough Loxacon capsules for 2 months The parameters to be tested
WOMAC test
VAS
EQ-5D-5L quality of life test
Goniometer angle measurement The test is completed by patients who participated in more than 70 of the treatment Monitoring of side effects It is the duty of the doctor of the given center - who reports to the investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None