Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: CL22202: 200 mg per day, One capsule daily in the morning after breakfast for 120 days
Control Intervention1: Placebo: One capsule daily in the morning after breakfast for 120 days
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ambulatory, male and female subjects aged 45-70 years with a Body Mass Index (BMI) of 22 to 29 kg/m². 2.Subjects diagnosed with Knee osteoarthritis grade II of Kellgren and Lawrence based on X-ray. 3.Subjects experiencing knee pain of 40-70 mm on a 100 mm visual analog scale (VAS). 4.Willing to refrain from using glucosamine, chondroitin, MSM, boswellia, turmeric, any other joint supplements, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDs (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial. 5.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 6.Results of screening are within normal range or considered not clinically significant by the Principal Investigator. 7.Subjects to discontinue the use of supplementations including vitamins, any other joint supplements, herbals, or other topical applications. 8.Agree to participate in the study through a written informed consent. 9.Willing to comply with all study-related activities. 10.No history of rheumatoid arthritis. 11.No bilateral end-stage knee OA.
Exclusion criteria
Exclusion criteria: 1.Previous injury and/or surgery to the knee. 2.Subjects who underwent treatment for COVID-19 within the last 3 months or tested positive during the study. 3.Expectation of surgery during the study period. 4.Subjects with uncontrolled Diabetes (FPG greater than 126 mg/dL) and Hypertension (Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg). 5.Subjects suffering from COPD or with a history of any respiratory or breathing disorders. 6.Subjects who have used any immunosuppressive drugs in the last 6 months (including steroids or biologics) or those with a history of immune system and autoimmune disorders or diseases, including Systemic Lupus Erythematous (SLE). 7.Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period. 8.Subjects with known allergies to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, or who have a suspected hypersensitivity, allergy, or sensitivity to herbal products. 9.Subjects who have taken acetaminophen/paracetamol, ibuprofen, aspirin, or other NSAIDs, or any herbal products within 7 days prior to the screening visit (visit 1). 10.Subjects who have taken any corticosteroid, indomethacin within 1 month prior to enrollment, or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment. 11.History of congestive heart failure or any vascular conditions. 12.Subjects with HIV positive status. 13.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 14.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers (greater than 5 cigarettes per day). 15.History of psychiatric disorders that may impair the ability of subjects to provide written informed consent. 16.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 17.History of heart, liver, lung cancer or chronic diseases. 18.Allergies to any ingredient in the investigational products. 19. Subjects with history of knee replacements. 20.Subjects currently engaged in a weight loss program or using weight loss medications. 21.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in : Total WOMAC scoreTimepoint: Days 1, 14, 30, 60, 90 and 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: WOMAC subscales (pain, stiffness, physical function) Timepoint: Days 1, 14, 30, 60, 90 and 120 ;Pain using Visual Analogue Scale (VAS) - 100 mm Timepoint: Screening Visit, Days 1, 14, 30, 60, 90 and 120;Lequesneâ??s Functional Index (LFI) Timepoint: Days 1, 14, 30, 60, 90 and 120;Six-minute walk test (SMWT) Timepoint: Days 1, 30, 60, and 120;Chair stand test (30SCST) Timepoint: Days 1, 30, 60, and 120;Primary Knee flexion range of motion Timepoint: Days 1 and 120;Isometric Knee torque (using EasyForce dynamometer) Timepoint: Days 1, 30, 60, and 120;Perceived Stress Scale (PSS-10) Timepoint: Days 1, 14, 30, 60, 90 and 120;Athens Insomnia Scale (AIS) Timepoint: Days 1, 14, 30, 60, 90 and 120;Kellgren and Lawrence grade Timepoint: Screening Visit and 120;Quality of life Short Form-36 (SF-36) questionnaire Timepoint: Days 1, 30, 60, and 120;Memory questionnaire (Mini-Cog©) Timepoint: Days 1, 30, 60, and 120;Serum Biomarkers (hs-CRP, TNF-alpha, MMP-3, COMP-1 and IL-6) Timepoint: Days 1 and 120;Urinary CTX-II (normalized by Creatinine) Timepoint: Days 1 & 120;Total Anti-Oxidant Capacity (TAC) Timepoint: Days 1 and 120;Use of Rescue medicationTimepoint: Days 1, 14, 30, 60, 90 and 120 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed