Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: Axtragyl®: Axtragyl® administered as a capsule. Each recruited patient will orally intake two 240mg capsule once a day after breakfast for 28 days.
Control Intervention1: Placebo: Place
Sponsors
GIELLEPI S.p.A
Eligibility
Inclusion criteria
Inclusion criteria: 1.Physically active healthy subjects (both women and men) without any joint’s diseases including osteoarthritis as well as rheumatoid arthritis. 2. Adult subjects (18 - 60 years old) experiencing joint (knee) pain (not associated with acute injury or long-standing disease). 3. Subjects should not have knee pain at rest but mild to moderate knee joint pain after 6 min walk test at a moderate-to brisk pace. 4. BMI 5. Subjects with normal ECG readings on screening. 6. Subjects with normal creatine kinase. 7. Patients ready to give written informed consent and willing to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Consuming any herbal supplement/drug, including both systemic and local ones, showing anti-inflammatory and/or analgesic action. 2. Subjects with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. 3. Subjects with uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. 4. Subjects with known history or diagnosis of osteoarthritis and rheumatoid arthritis as well as other joint disease. 5. Subjects with joint surgery during 3 months before screening.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg). 7. Cancer and any other diseases interfering with study procedures or safety. 8. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 9. Presence of any severe medical or psychological condition or chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study. 10. Participation in any other clinical study within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement of knee pain using assessment VAS after 6-minute walk test. 2.Change in WOMAC score. 3. Improvement in SCT. 4. Improvement in (range of motion) ROM. 5. Reduction of CRP. 6.Overall Assessment of treatment satisfaction & tolerability.Timepoint: Baseline Day 5 14 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Physical Examination 2.Vital Signs: Pulse rate, blood pressure & body temperature 3.Lab assessment 4.Adverse Event AssessmentsTimepoint: Screening & Day 28 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd
Outcome results
None listed