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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nocturnal Leg Cramps
- Sponsor
- Naveh Pharma LTD
- Enrollment
- 216
- Locations
- 7
- Primary Endpoint
- The number of episodes of NLC
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
The number of episodes of NLC
Time Frame: 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.
The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
Secondary Outcomes
- Change in quality of life (SF-36)(The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.)
- Drop-out rate(The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.)
- Duration of NLC(The difference in duration 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.)
- Severity of pain associated with NLC(The difference in severity of pain 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.)
- Changing in the sleep quality(The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.)