CompletedNot Applicable

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

Ukraine216 participantsStarted 2018-02-09

Plain-language 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

Who can participate

Age range45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The number of episodes of NLC

Timeframe: The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

Trial details

NCT IDNCT03807219

SponsorNaveh Pharma LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-27

View on ClinicalTrials.gov More Nocturnal Leg Cramps trials