Nocturnal Leg Cramps
Conditions
Keywords
nocturnal legs cramps, legs cramps, NLC
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).
Interventions
DIETARY_SUPPLEMENTMagnox Comfort
Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
OTHERPlacebo
placebo
Sponsors
Naveh Pharma LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. A study subject is a man or a woman over the age of 45 years; 3. The study subject has an established diagnosis of the nocturnal legs cramps; 4. The study subject understands the Ukrainian language; 5. The study subject has satisfactory results of the neurological examination of both lower extremities; 6. The study subject has a telephone and can use it permanently;
Exclusion criteria
1. The onset of one of the non-inclusion criteria; 2. The study subject has less than 4 episodes of NLC during the 14-day screening period; 3. There is necessity for significant change in the treatment tactics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of episodes of NLC | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | The study subject will record the length of cramps in the diary |
| 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. | The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10 |
| 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. | Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation. |
| 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. | The evaluation will be conducted using VAS (visual analog scale) from 0 to 5 |
| 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. | Counts of drop-out subjects |
Countries
Ukraine
Outcome results
None listed