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

Naveh Pharma LTD216 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

216

Conditions

Nocturnal Leg Cramps

Interventions

Magnox ComfortDIETARY_SUPPLEMENT

Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).

PlaceboOTHER

placebo

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (7)

Kharkiv City Clinic №9

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Kyiv city clinic №9

Kyiv, Kyiv Oblast, Ukraine

Medical Center "Artem"

Kyiv, Kyiv Oblast, Ukraine

Medical Center "Preventclinic" LLC

Kyiv, Kyiv Oblast, Ukraine

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

Duration of NLC

The study subject will record the length of cramps in the diary

Time frame: 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 study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10

Time frame: 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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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