Status:
COMPLETED
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Lead Sponsor:
Naveh Pharma LTD
Conditions:
Nocturnal Leg Cramps
Eligibility:
All Genders
45+ years
Phase:
NA
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 Co...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2018
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03807219
Start Date
February 9 2018
End Date
August 27 2018
Last Update
January 16 2019
Active Locations (7)
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1
Kharkiv City Clinic №9
Kharkiv, Kharkivs’ka Oblast’, Ukraine
2
Kyiv city clinic №9
Kyiv, Kyiv Oblast, Ukraine
3
Medical Center "Artem"
Kyiv, Kyiv Oblast, Ukraine
4
Medical Center "Preventclinic" LLC
Kyiv, Kyiv Oblast, Ukraine