Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03807219
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2019-01-09
Brief Title:
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Sponsor:
Naveh Pharma LTD
Organization:
Naveh Pharma LTD
Study Overview
Official Title:
A Randomized Multicenter Prospective Double-blind Placebo-controlled Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Status:
COMPLETED
Status Verified Date:
2019-01
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:
A randomized multicenter prospective double-blind placebo-controlled clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps
Detailed Description:
At the beginning of the study study subjects undergo a 14-day screening period during which the number of episodes of NLC is recorded For further participation in the study they must have at least 4 NLC episodes Thereafter an examination of compliance with the study requirements is performed and study subjects are randomized to one of the two groups for a 60-day of IP use 1 capsule of Magnox Comfort daily or to the control group 1 capsule of placebo daily
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