A Prospective, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Smoothwalk Tablets in Reducing the Symptoms of Knee Osteoarthritis.
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Current pharmacological treatments primarily provide palliative relief from symptoms without addressing the underlying cartilage disorder. Additionally, prolonged use of these treatments may lead to serious side effects, such as gastrointestinal problems, cardiovascular risks, and further cartilage damage. On the other hand, nutritional interventions provide a continuous strategy for managing and potentially preventing OA, serving as a valuable supplement to conventional OA treatments.12,13
The underlying cause of articular damage stems from an imbalance between anabolic and catabolic processes, which can be modulated by dietary compounds like nutraceuticals. Due to their minimal side effects, particularly over the long term, as well as their ease of extraction and low production
Clinical Trial Protocol: CP-SMW001-25
Version 1.0, Dated: 26 Jun 2025
costs, nutraceuticals may offer a viable approach for the preventive management of osteoarthritis (OA).14 In recent years, there has been growing interest in nutraceutical supplements, which consist of a varied group of molecules with significant potential to reduce inflammation, oxidative stress, pain, and joint stiffness, while also promoting cartilage formation.13,15
Hence, this prospective, multicenter, open-label, single-arm study will evaluate the efficacy and safety of Smoothwalk tablets of Lee Health Domain (I) Pvt. Ltd. for the treatment of knee osteoarthritis.
Primary Objective
• To evaluate the efficacy of Smoothwalk tablets in the treatment of patients with osteoarthritis and determine the Minimal Clinically Important Difference (MCID).
Secondary Objective
• To evaluate the impact of Smoothwalk tablets on the arthritis/joint pain intensity in patients with osteoarthritis.
• To evaluate the safety of Smoothwalk tablets in the treatment of patients with osteoarthritis.
Exploratory Objective
• To evaluate the impact of Smoothwalk tablets on food intake in patients with osteoarthritis.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 45.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female subjects aged greater than or equal to 45 years
- •Subjects who are diagnosed with Osteoarthritis and confirmed x-rays showing radiographic evidence consistent with Kellgren-Lawrence Grade 2 or 3 as per Annexure
- •Primary OA according to American College of Rheumatology (ACR) clinical and radiographic criteria as per Annexure 2
- •Subjects who understand the nature of the study and provide written informed consent
- •Subjects who are cooperative, reliable, and agree to comply with protocol procedures 6.
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
- •Immune-inflammatory joint disease, rheumatoid arthritis, systemic connective tissue disease, systemic red lupus etc
- •Subjects with a history of gout
- •Presence or suspicion of drug, alcohol, or drug addiction
- •Use of glucocorticosteroids within 1 month prior to the baseline visit
- •Use of NSAIDs less than 3 weeks before baseline.
- •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
- •Subjects suffering from any chronic illness that could interfere with the current study, as determined by the clinical investigator.
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: - 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 Outcomes
- Change in the mean total score of VAS at the end of study visit compared to baseline.(- Visit 1: Screening/Baseline)
- Proportion of subjects who used rescue medication during the treatment period compared from baseline to the end of the study.(- Visit 1: Screening/Baseline)
- Incidence of Adverse Events and Serious Adverse Events throughout the trial duration, including clinically significant laboratory change(s) that occur during the study.(- Visit 1: Screening/Baseline)
- Change in the mean total scores of Food Frequency Questionnaire (FFQ) at the end of study visit 4 (Day 90 ± 3) compared to baseline.(- Visit 1: Screening/Baseline)
Investigators
Dr Prabhakar Kolkamuri
Techsol Life sciences Private Limited