Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Darfax: Darfax administration as tablet.
Each recruited patient will orally intake one tablet 2 times a day for 20
days.
Control Intervention1: Placebo: Placebo administration as table
Sponsors
International Health Science Srl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female subjects (age 30-50 yrs). 2. Adult subjects with acute ankle sprain (grade I or II) 3. Able to communicate adequately with the investigator and to comply with the requirements for the entire study 4. Patient should be able to give written informed consent prior to participating in the study
Exclusion criteria
Exclusion criteria: 1. Steroidal anti-inflammatory drugs, NSAIDs. 2. Hypersensitivity to any components of the investigational dietary supplement. 3. Fractures (ankle and joints) diagnosed at RX. 4. Grade 3 sprain (near total loss of function, positive anterior drawer and talus tilt tests, extensive bruising / haemorrhage, great insertional pain, joint limitation > 10 °, edema > 2.0 cm). 5. Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, psychiatric diseases, blood disorders, gastrointestinal diseases). 6. Treatment with anticoagulants and Diuretics. 7. Pregnancy and breastfeeding women. 8. Participation in concomitant interventional clinical study or during the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Odema. Reduction of pain. Minimum day taken for pain to reduce by using VAS. This questionnaire will be send to the subjects to fill when not coming to the clinic. Change in Foot and Ankle Outcome Score (FAOS). All these will be assessed on Day 7 and Day 20 from baseline. Improvement in HRQL SF-36. Overall treatment satisfaction. Overall assessment of tolerability.Timepoint: Screening, Day 7 and Day 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Physical Examination 2.Vital Signs: Pulse rate, blood pressure and body temperature 3.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation 4. Adverse Event AssessmentsTimepoint: Screening and Day 20 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd.
Outcome results
None listed