Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere Health Condition 2: null- Idiopathic muscle cramps
Conditions
Interventions
Intervention1: Vitamin K2-7: Each capsule of 100 mcg to be given two times in a day orally for 3 months.
Control Intervention1: No comparator agent: No comparator agent
Sponsors
Viridis BioPharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Men & women with idiopathic muscle cramps (cramp will be defined as a painful contraction of any muscle group in the leg, which was either precipitated by certain movements, aborted by procedures involving stretch of the affected muscle or which was associated with a palpable hardening of the muscle. To qualify for trial inclusion, subjects should have a stable pattern of two or more cramps per week for three months. 2. Willing to participate in the trial
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Subjects with physiological conditions causing cramps like pregnancy or during sports activity 2. Patients with severe neurological, muscular, psychiatric, endocrinological, metabolic medical conditions or vascular diseases, electrolyte imbalance, liver cirrhosis causing muscle cramps will be excluded 3. Subjects on drugs which are likely to affect muscle cramps 4. Subjects with any known hypersensitivity to Vitamin K 5. Patients with any cancers receiving chemotherapy/ radiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in number, duration and severity of cramps after treatment as compared to baselineTimepoint: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The subjectâ??s assessment of whether treatment was effective and any other change noticed in health while on treatment 2.To assess any carry-over effect of the treatmentTimepoint: 4 months | — |
Countries
India
Contacts
Public ContactDr Yogesh Dound
Viridis BioPharma Pvt. Ltd.
Outcome results
None listed