Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Smoothwalk: Smoothwalk is administered orally twice daily with lukewarm water, before meals.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
LEE HEALTH DOMAIN (I) PVT. LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged greater than or equal to 45 years 2. Subjects who are diagnosed with Osteoarthritis and confirmed x-rays showing radiographic evidence consistent with Kellgren-Lawrence Grade 2 or 3 as per Annexure 1. 3. Primary OA according to American College of Rheumatology (ACR) clinical and radiographic criteria as per Annexure 2 4. Subjects who understand the nature of the study and provide written informed consent 5. Subjects who are cooperative, reliable, and agree to comply with protocol procedures 6. Women of childbearing potential must have a negative pregnancy test at screening, or have had a hysterectomy, or have gone through menopause for more than 2 years
Exclusion criteria
Exclusion criteria: 1.Pregnancy, lactation, or planning pregnancy during the study period. 2.Individual intolerance to the active or excipients of the dietary supplement - Smoothwalk Tablets (collagen type II + Natural Eggshell Membrane + Glucosamine Hydrochloride + Curcumin + Boswellia serrata extract + Calcium Ascorbate (vitamin C) + Vitamin D3). 3.Intolerance to eggs, poultry 4.History of trauma or surgery on the target joint other than diagnostic arthroscopy more than 60 days old at study entry, or expected surgery within 6 months following inclusion 5. Immune-inflammatory joint disease, rheumatoid arthritis, systemic connective tissue disease, systemic red lupus etc 6. Subjects with a history of gout 7. Presence or suspicion of drug, alcohol, or drug addiction 8. Use of glucocorticosteroids within 1 month prior to the baseline visit 9. Use of NSAIDs less than 3 weeks before baseline. 10. The need for stable use of glucocorticosteroids in any dosage form 11.Use of w-3 polyunsaturated fatty acid preparations in the 6 months prior to study participation (a 2-week washout period is allowed), therapeutic doses of fish or vegetable oils (greater than or equal to 2 g/day), shark cartilage preparations 12. Subjects suffering from any chronic illness that could interfere with the current study, as determined by the clinical investigator. 13. Participation in another clinical study at present or in the previous 30 days or 5 half-lives (whichever is longer) prior to the Screening Visit. After assessment of the subject, subject inclusion will be at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of study visit 4 (Day 90 3) compared to baseline.Timepoint: - Visit 1: Screening/Baseline - Visit 2: Follow-up (Day 30 3) - Visit 3: Follow-up (Day 60 3) - Visit 4: End of Study (Day 90 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean total score of VAS at the end of study visit compared to baseline.Timepoint: - Visit 1: Screening/Baseline - Visit 2: Follow-up (Day 30 3) - Visit 3: Follow-up (Day 60 3) - Visit 4: End of Study (Day 90 3);Proportion of subjects who used rescue medication during the treatment period compared from baseline to the end of the study.Timepoint: - Visit 1: Screening/Baseline - Visit 2: Follow-up (Day 30 3) - Visit 3: Follow-up (Day 60 3) - Visit 4: End of Study (Day 90 3);Incidence of Adverse Events and Serious Adverse Events throughout the trial duration, including clinically significant laboratory change(s) that occur during the study.Timepoint: - Visit 1: Screening/Baseline - Visit 2: Follow-up (Day 30 3) - Visit 3: Follow-up (Day 60 3) - Visit 4: End of Study (Day 90 3);Change in the mean total scores of Food Frequency Questionnaire (FFQ) at the end of study visit 4 (Day 90 3) compared to baseline.Timepoint: - Visit 1: Screening/Baseline - Visit 2: Follow-up (Day 30 3) - Visit 3: Follow-up (Day 60 3) - Visit 4: End of Study (Day 90 3) | — |
Countries
India
Contacts
Public ContactDr Laxmana Kumar Jakkala
Techsol Life sciences Private Limited
Outcome results
None listed