Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612986
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2018-07-04
Brief Title:
Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis
Sponsor:
River Pharma Srl
Organization:
River Pharma Srl
Study Overview
Official Title:
Double Blind Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid HA and Acetyl-11-Keto-Beta-Boswellic Acid AKBA in Patients Affected by Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2019-09
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:
SMILE
Brief Summary:
Double blind placebo controlled trial to evaluate the effects of a nutraceutical containing high-molecular-weight hyaluronic acid HA and acetyl-11-keto-beta-boswellicacid AKBA in patients affected by knee osteoarthritis
Detailed Description:
The primary objective of the trial is to assess the feasibility of implementing Ultrasonography and Range of Motion ROM as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing hyaluronic acid HA
The secondary objectives of the trial are
to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction optional
to evaluate the enrollment rate in one month
The explorative objectives of the trial are
Preliminary data on efficacy of the tested product
The secondary objectives of the trial are
to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction optional
to evaluate the enrollment rate in one month
The explorative objectives of the trial are
Preliminary data on efficacy of the tested product
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