Trial | NCT03807219  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    216
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
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 Started
Feb 09
2018
Primary Completion
Aug 27
2018
Study Completion
Aug 27
2018
Last Update
Jan 16
2019

Dietary Supplement Magnox Comfort [magnesium, vitamin e, pyridoxine]

Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).

Other Placebo

placebo

Magnox Comfort Active Comparator

80 subjects will be on the Magnox Comfort arm.

Placebo Placebo Comparator

80 subjects will be on the Placebo arm.

Criteria 

Inclusion Criteria:

The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
A study subject is a man or a woman over the age of 45 years;
The study subject has an established diagnosis of the nocturnal legs cramps;
The study subject understands the Ukrainian language;
The study subject has satisfactory results of the neurological examination of both lower extremities;
The study subject has a telephone and can use it permanently;

Exclusion Criteria:

The onset of one of the non-inclusion criteria;
The study subject has less than 4 episodes of NLC during the 14-day screening period;
There is necessity for significant change in the treatment tactics.
No Results Posted