None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 40 years or older. 2) Participants who have experienced Nocturnal Leg Cramps during sleep at an average frequency of at least two times per week over the past two weeks. 3) Participants who have voluntarily provided written informed consent to participate in this human application study.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women, or women of childbearing potential who do not agree to use an effective method of contraception during the study period. 2) Participants with severe medical conditions (e.g., liver cirrhosis, end-stage renal disease). 3) Participants with a history of malignant tumors. 4) Participants currently taking anticoagulant medications. 5) Participants who have participated in another clinical trial within the past 3 months. 6) Participants who are deemed inappropriate for participation in this study at the investigator’s discretion. 7) Participants currently taking diuretics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in the weekly frequency of Nocturnal Leg Cramp | — |
Secondary
| Measure | Time frame |
|---|---|
| in duration of Nocturnal Leg Cramp (minutes);duration of Nocturnal Leg Cramp (minutes) per episode;pain severity (NRS);Insomnia Severity Index(ISI) | — |
Countries
Korea, Republic of
Contacts
Wonkwang University