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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnox Comfort | Active Comparator | 80 subjects will be on the Magnox Comfort arm. |
|
| Placebo | Placebo Comparator | 80 subjects will be on the Placebo arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnox Comfort | Dietary Supplement | Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of episodes of NLC | The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of NLC | The study subject will record the length of cramps in the diary | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nitsan Primor | Naveh Pharma LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kharkiv City Clinic №9 | Kharkiv | Kharkiv Oblast | Ukraine | |||
| Kyiv city clinic №9 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34719399 | Derived | Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9. |
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| ID | Term |
|---|---|
| D020922 | Sleep-Wake Transition Disorders |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Placebo | Other | placebo |
|
The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10 |
| 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. |
| Change in quality of life (SF-36) | 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. | 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. |
| Changing in the sleep quality | The evaluation will be conducted using VAS (visual analog scale) from 0 to 5 | 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. |
| Drop-out rate | Counts of drop-out subjects | 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. |
| Kyiv |
| Kyiv Oblast |
| Ukraine |
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