Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Juvecol K: One capsule (50 mg) will be taken orally with water once daily after breakfast for duration of 16 Weeks
Control Intervention1: Placebo: One capsule (50 mg) will be taken oral
Sponsors
Naturetech co Ltd
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects aged between 40-70 years with body mass index (BMI) of 18.5 - 29.9 kg/m2 2.Subjects with radio graphic evidence by Kellgren-Lawrence grade 1 or 2 3.One knee joint (or most painful knee joint among the two) with a VAS score of 30-70 mm 4.Subjects with sedentary lifestyle, no regular athletic or sports activities 5.Subject agrees to maintain diet tracker 6.Subject considered generally healthy as per health history and routine clinical investigations during screening. 7.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit 8.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent
Exclusion criteria
Exclusion criteria: 1.Routine use of dietary supplements containing proteoglycans,hyaluronic acid, N-acetyl glucosamine, glucosamine,chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement within 3 months prior to enrolment 2.Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear 3.History of underlying inflammatory arthropathy or Gout or severe RA or OA 4.Clinical history of bone or cartilage disorders including fracture and distortion within one year prior to enrolment 5.Have taken any Intra-articular or Oral corticosteroids,indomethacin, glucosamine + chondroitin, within 3 monthsprior to screening visit (Visit 1) or intra-articular treatment/injections with hyaluronic acid within 6 months preceding the treatment period. 6.Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation 7.Expectation of surgery during the study duration period. 8.Female subjects, who are pregnant, breast feeding or planning to become pregnant 9.Fasting blood glucose level should be greater than 125 mg/dl. 10.Subject having known allergy to non-steroidal antiinflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to investigational product or any other related products 11.Have taken acetaminophen/ paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the screening visit (Visit 1) 12.Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders 13.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol 14.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 15.History of congestive heart failure or any vascular conditions. 16.Subjects with HIV Positive status. 17.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded. 18. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism 19.History of Systemic Lupus Erythematous (SLE) 20.Subjects consuming alcohol (Greater than 5 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). 21.Any other condition that, in the opinion of the investigator, would adversely affect the subject"s ability to complete the study or its measures. 22.Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in total WOMAC scoreTimepoint: Day 1 (Baseline), Week 2, Week 4,Week 8, Week 12 & Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Serum cartilage biomarker-Cartilage Oligomeric Matrix Protein (COMP)Timepoint: Day 1 (Baseline ) & Week 16;Change from baseline to the end of the study period in Global physical activity questionnaire (GPAQ)Timepoint: Day 1 (Baseline ) ,Week 2,Week 4,Week 8 ,Week 12 & Week 16;Change from baseline to the end of the study period in Joint space (using Digital X-ray)Timepoint: Screening & Week 16;Change from baseline to the end of the study period in Knee flexion range of motionTimepoint: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in Physician Global Assessment (PGA) and Subjective Global Assessment (SGA)Timepoint: Week 2,Week 4,Week 8 ,Week 12 & Week 16;Change from baseline to the end of the study period in Serum cytokine levels (IL-6, IL-1ß, TNF-a, MMP-3 levels)Timepoint: Day 1 (Baseline ) & Week 16;Change from baseline to the end of the study period in Six-minute walk test (SMWT)Timepoint: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in Timed Up and Go test (TUG)Timepoint: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in total in WOMAC subscales (pain, stiffness and physical function)Timepoint: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16;Change from baseline to the end of the study period in Urinary levels of CTX IITimepoint: Day 1 (Baseline ) & Week 16;Change from baseline to the end of the study period in Visual Analogue Scale (VAS)Timepoint: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 | — |
Countries
India
Contacts
Public ContactAlluri Venkata Krishna Raju
Laila Nutraceuticals
Outcome results
None listed