Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: ARTHRITY Pack consisting of ARTHRITY
Modulate-750mg plus ARTHRITY
Resolution-500mg: Twice daily after meals for 90 plus 2 days
Control Intervention1: NA: Their is no comparator agent
Sponsors
Dr Vaidya and Mr Madhusudan
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participants aged between 40 and 65 years both inclusive at the time of screening. 2.Participants with radiographically confirmed osteoarthritis OA of the knee classified as Kellgren Lawrence Grade 1 to Grade 3. 3.Participants having a baseline WOMAC pain subscale score of greater or equal to 30 out of 100 at Screening or Baseline indicating the presence of clinically relevant knee pain symptoms. 4.Participants willing to comply or perform study treatments including questionnaires. 5.Participants able to give written informed consent and willingness to participate in the study and comply with respective procedures.
Exclusion criteria
Exclusion criteria: 1.Participants with severe osteoarthritis of the knee classified as Kellgren Lawrence KL Grade 4. 2. Participants with a history of prior knee surgery or those currently requiring surgical intervention for knee osteoarthritis. 3. Participants diagnosed with rheumatoid arthritis, inflammatory arthritis, or any autoimmune disease that may interfere with study assessments. 4. Participants with regular use of non steroidal anti inflammatory drugs NSAIDs, defined as use more than two times per week, within the recent period prior to screening. 5. Participants who have received intra articular IA corticosteroid injections or hyaluronic acid HA injections in the target knee within the last 2 months prior to screening. 6. Participants with clinically significant hepatic, renal, metabolic, or other uncontrolled systemic disorders that, in the opinion of the Investigator, may interfere with study participation or interpretation of study results. 7. Participants with a known allergy or hypersensitivity to seafood or any component of the Investigational Product. 8. Participants who have participated in another clinical trial or received any investigational product within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index WOMAC total score from baseline to end of the studyTimepoint: Day 1, Day 8, Day 30 , Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in serum Interleukin 6 IL6 levels from Baseline to Day 90 in a subgroup of the first 06 participants enrolled in the study.Timepoint: Day 1, Day 8, Day 30 , Day 90 | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
BioAgile therapeutics Private Limited
Outcome results
None listed