A study to understand the effectiveness of a new product on adult subjects with ankle pain and discomfort.

Not Applicable

Completed

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2022/08/044883
• Lead Sponsor: International Health Science Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-21
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of Odema. <br/ ><br>Reduction of pain. <br/ ><br>Minimum day taken for pain to reduce by using VAS. This <br/ ><br>questionnaire will be send to the subjects to fill when not coming to <br/ ><br>the clinic. <br/ ><br>Change in Foot and Ankle Outcome Score (FAOS). <br/ ><br>All these will be assessed on Day 7 and Day 20 from baseline. <br/ ><br>Improvement in HRQL SF-36. Overall treatment satisfaction. <br/ ><br>Overall assessment of tolerability.Timepoint: Screening, Day 7 and Day 20 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Physical Examination <br/ ><br>2.Vital Signs: Pulse rate, blood pressure and body temperature <br/ ><br>3.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation <br/ ><br>4. Adverse Event AssessmentsTimepoint: Screening and Day 20