Health Condition 1: null- Acute Pain associated with Muscle Spasm and Inflammatory Conditions Health Condition 2: M629- Disorder of muscle, unspecified
Conditions
Interventions
Intervention1: Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma): Three Capsules Daily for a period 7 days
Control Intervention1: Flupirtine maleate capsule 100 mg: Three Capsules Daily for a
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test). 2.Written informed consent by patient. 3.Patient willing to follow up. .
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing females. 2.Patient with impaired hepatic function defined as SGOT or SGPT 2.0 times the upper limit of the normal 3.Patient with impaired renal function, confirmed by serum creatinine 2.0 mg/dL 4.Patient who had participated in a medical, surgical or pharmaceutical investigation at the time of the study in which an investigational new drug was dispensed to the patient within last 6 months 5.Patient with history of hypersensitivity of Flupirtine and any topical analgesic preparations like balm, gel etc 6.Patients with Bile Outflow Disorders. 7.Patients with alcoholic abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Restriction of Movement ScoreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Changes in Restriction of Movement ScoreTimepoint: Day 0, Day 3, Day 5 and Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Symptoms such as Stiffness, Swelling, Tenderness and Redness shall be evaluated at baseline and each visitTimepoint: Day 0, Day 3, Day 5 and Day 7.;Improvement in Patients and Physicians Global Assessment of PainTimepoint: Day 7 | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed