Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Low molecular weight
chondroitin sulfate sodium: Dose: 300mg capsule containing 100 mg of Low molecular weight chondroitin sulfate sodium
Dosage form: Capsules
Route of administration:
Sponsors
Daehan Chemtech Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Ambulatory male and female subjects 40 to 75 years of age 2 KL Kellgren Lawrence grade of 1 to 2 3 At least 30 on 100 mm visual analogue scale 4 Subjects having mild to moderate pain in knee joint upon completion of 6 minute walk test stair climb test and 30 second chair stand test and otherwise no knee pain at rest 5 Subjects willing to refrain from taking ibuprofen aspirin or other NSAIDs or any other pain reliever OTC or prescription during the entire trial 6 Subjects willing to sign the informed consent and comply with study procedure
Exclusion criteria
Exclusion criteria: 1.Subjects with evidence or history of clinically significant joint disorders other than mild knee osteoarthritis, including joint dislocation or quadriceps tendon tear. 2.Subjects with history of underlying inflammatory arthropathy or severe RA or OA. 3.Subjects who used immunosuppressive drugs during the last 6 months, including steroids or biologics, or who have a history of immune system or autoimmune disorders. 4.Subjects with a history of knee or hip joint replacement surgery, or hip or back pain that interferes with walking. 5.Subjects with BMI less than 18.5 or more than 30. 6.Subjects who consumed medicines or supplements related to joint health within 30 days before the screening visit. 7.Subjects considered unsuitable for the study by the Principal Investigator. 8.Subjects with a history of tobacco smoking. 9.Subjects expecting surgery during the study period. 10.Female subjects who are pregnant, breastfeeding, or planning to become pregnant. 11.Subjects with known allergy to non steroidal anti inflammatory drugs, NSAIDs, including aspirin, or suspected hypersensitivity or allergy to herbal products. 12.Subjects with any physical disability that could interfere with their ability to perform the functional performance measures included in this protocol. 13.Subjects with a history of gout. 14.Subjects who received corticosteroids, glucosamine, or chondroitin within 90 days before the screening visit, or any intra articular treatment or corticosteroid or hyaluronic acid injection within 90 days before the screening visit. 15.Subjects with a history of congestive heart failure or vascular disease. 16.Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic disease, malignancy, or hypothyroidism, as judged by the Investigator. 17.Subjects with a history of systemic lupus erythematosus, SLE. 18.Subjects with a history of high alcohol intake, more than 2 standard drinks per day. 19.Subjects with psychiatric disorders that may impair their ability to provide written informed consent. 20.Subjects who participated in any investigational or marketed product trial within 90 days before the screening visit. 21.Subjects currently taking, or who took within 30 days before the screening visit, prescription or OTC pain relievers such as acetaminophen, paracetamol, ibuprofen, aspirin, other NSAIDs, or natural health products, excluding vitamins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in WOMAC total score and subscores, pain, stiffness, and physical function. 2.Change in Pain VAS. 3.Change in Lequesne Functional Index total score and subscores, presence of pain or discomfort, maximum walking distance, and difficulties of daily life.Timepoint: Day 0, Day 7, Day 30, Day 45, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in 6 minute walk test 2.Change in stair climb test. 3.Change in 30 second chair stand test. 4.Change in joint space narrowing width. 5.Change in knee flexion from Timepoint: Day 0, Day 7, Day 30, Day 45, Day 90.;6.Change in TNF alpha levels. 7.Change in high sensitivity C Reactive Protein hs CRP levels. 8.Change in cyclooxygenase 2 COX 2 levels. 9.Change in cartilage oligomeric matrix protein COMP levels. 10.Change in urine C telopeptide of type II collagen uCTX II levels. safety Hematology, Serum Biochemistry & UrinalysisTimepoint: Day 0 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Manju Jayaram
Bangalore Clinical Services
Outcome results
None listed