NCT03807219

The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Naveh Pharma LTD · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nocturnal Leg Cramps

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Magnox Comfort	Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
OTHER	Placebo	placebo

Timeline

• Start date: 2018-02-09
• Primary completion: 2018-08-27
• Completion: 2018-08-27
• First posted: 2019-01-16
• Last updated: 2019-01-16

Locations

7 sites across 1 country: Ukraine