None listed
Conditions
Interventions
Intervention1: Arm 1: Collagen type II (40 mg/day): 4 capsules per day for 180 days
Intervention2: Arm 2: Collagen type II (80 mg/day): 4 capsules per day for 180 days
Intervention3: Arm 3: Collagen t
Sponsors
Dr Shalini Srivastava
Eligibility
Inclusion criteria
Inclusion criteria: 1. Physically active male and female both, aged >= 20 to 2. Subject with a history of 4-9 months related to knee joint pain aggravation on physical stress. 3. Body mass index (BMI) >= 20 and 4. Fasting blood glucose (FBG) 5. Subject with self-reported joint pain of >= 70 mm on a 100-point VAS scale after 10±2 minutes of walking on a treadmill using modified Naughton protocol. 6. Subject with pain 7. Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria. 8. The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements. 9. The subject is willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period. 10. Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Obese Subject with BMI > 29.9 kg/m2. 2. Subjectâ??s inability to complete the exercise protocol of 10±2 minutes at screening. 3. Subject with the clinical diagnosis of any form of joint disease such as Osteoarthritis (OA). 4. Subject with the clinical diagnosis of any form of autoimmune disorder related to the joint such as Rheumatoid arthritis (RA). 5. A subject suffering from Insomnia and restless leg syndrome. 6. Uncontrolled hypertensive defined as subject currently on an anti-hypertensive drug with systolic Blood Pressure >= 140 mm Hg and/ or & diastolic blood pressure >= 90 mm Hg 7. Uncontrolled diabetics currently on anti-diabetic medication with Fasting blood glucose (FBG) >= 126 mg/ dl. 8. Systolic Blood Pressure >= 140 mm Hg and/ or & diastolic blood pressure >= 90 mm Hg 9. The subject who have been injured near the knee joint region in the past six months. 10. Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes. 11. The subject who have used Intra-articular injections and or steroids for joint health issues in the last six months. The subjects who have undergone a significant cardiovascular event in the past six months. 12. The subject who have any other chronic disease or condition or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the subject at unacceptable risk the for the subject in the study or may interfere with evaluations in the study or noncompliance with treatment or visits. 13. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 14. The subject who have participated in a study of an investigational product 90 days prior to the screening. 15. Subject with a history of heavy alcohol consumption. 16. Smokers 17. Subject currently on joint health supplements for pain or inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of collagen on knee joint flexibility as assessed by the change in the range of motion (active flexion and extension) using goniometry as compared to placebo.Timepoint: from baseline Day 0 to end of study visit Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| A number of steps walked daily as assessed by average step count using a pedometer in Collagen groups compared to placebo and G & C.Timepoint: last 7 days before Day 0, 30, 60, 90, 120,150 and 180 visits;Change in the knee joint flexibility (Knee ROM active flexion and active-passive extension) as assessed by a range of motion (using goniometry) in Collagen groups versus the placebo group and the G & C groupTimepoint: from baseline (Day 0) to Day 30, 60, 90, 120, and 150;Change in the knee joint flexibility (Knee ROM Extension) as assessed by a range of motion (using goniometry) in the Collagen groups versus the G & C groupTimepoint: from baseline (day 0) to end of study visit (day 180);Knee joint pain as assessed by Pain visual analog scale (VAS) at the end of the stress exercise in Collagen groups versus the placebo and the G & C group.Timepoint: from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180;Quality of life (QoL) as assessed by change in European Quality of Life Five Dimension five-level (EQ-5D-5L) score as compared to the change into placebo and G & C groups.Timepoint: from baseline (Day 0) to the end of the study (day 180);Retrospective Joint Discomfort as assessed by the change in the Knee injury and Osteoarthritis Outcome Score (KOOS) as compared in the Collagen groups compared to placebo and G & C.Timepoint: from baseline (Day 0) (post-exercise) to follow up visit Day 5, 30, 60, 90, 120, 150 and day 180 (post-exercise);Subjects assessment for joint discomfort from daily activity as measured using Physical function domain modified Western Ontario and McMaster Universities Osteoarthritis Index (PF-mWOMAC) questionnaire in Collagen groups compared to placebo and G & C group.Timepoint: last 7 days before baseline (Day 0), Day 30, 60, 90, 120, 150, and 180 visits | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
Vedic Lifesciences Pvt Ltd
Outcome results
None listed